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FDA Reverses Course on COVID-19 Antibody Tests, Will Now Require Review and Approval

May 6, 2020, 12:19 PM
Publication Type(s):
Client Alerts
Exlcude on home page:
No

On May 4, 2020, the U.S. Food and Drug Administration (“FDA”) announced new restrictions on the marketing and distribution of serology tests used to identify antibodies to COVID-19 during the course of the public health emergency. Such tests, which can quickly indicate whether someone has been exposed to a particular pathogen, such as COVID-19, could prove critical in determining the level of population that has been exposed to the virus and has potentially developed immunity to further infection.

In an effort to allow valid tests to quickly become available, since mid-March, FDA had allowed for the manufacture and distribution of such tests without specific FDA approval, so long as the manufacturer (i) notified FDA of its intent to distribute the tests, (ii) affirmed that the tests were validated, and (iii) provided instructions for use containing required disclaimers, including that the test had not been reviewed by FDA and should not be used as the sole basis to diagnose an infection. However, since the publication of that policy, significant questions were raised about the validity and proper use of at least some tests being marketed.

In response, FDA published the new restrictions, outlined in FDA’s Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (revised May 4, 2020). The revisions make significant changes to the agency’s policy on COVID-19 antibody tests. Under the new guidance, FDA will now require the manufacturer or distributor to submit an Emergency Use Authorization (“EUA”) request and FDA will independently verify the manufacturer’s validation data. The new policy still allows for the distribution of validated tests prior to receiving an EUA, but companies must now prepare and submit an EUA within approximately 10 business days of distributing the tests. To help facilitate the process, FDA has developed an EUA template that is specific to such serology tests. If FDA identifies any concerns while reviewing an EUA submission, the agency has committed to providing companies with an opportunity to address any issues before initiating an enforcement action. If the manufacturer fails to file an EUA request within approximately 10 business days of beginning distribution, distribution is no longer authorized and must cease.

In addition to approving EUAs for individual tests, FDA has also issued an umbrella EUA for all antibody tests that have been independently validated by the National Institutes of Health’s National Cancer Institute or any other agency that FDA has designated to conduct such validation. Companies may voluntarily submit their test to the National Cancer Institute for independent validation and, if deemed eligible by FDA, may request that their test be added to the umbrella EUA. The National Cancer Institute has so far conducted validation testing on 13 antibody tests but has not yet released the data publicly.

Companies seeking to manufacture and distribute COVID-19 antibody tests are advised to engage FDA for a pre-EUA review early in the development process and should consider submitting their tests to the National Cancer Institute for independent validation. Companies who do so will be asked to sign a transfer agreement allowing that the test results be made publicly available. As of this writing, FDA has approved EUAs for 12 antibody tests and is currently reviewing submissions for an additional 200 tests. Distributors and consumers of antibody tests are advised to consult FDA’s website to ensure they are purchasing tests that have been properly validated. Those antibody tests that have received EUAs may be found on FDA’s website: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd.

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  1. rogerlagasca | Jul 06, 2020
    Excellent website you have here, so much cool information!.. managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา Hi! Thanks for the great information you havr provided! You have touched on crucuial points!
  2. rogerlagasca | Jul 06, 2020
    Positive site, where did u come up with the information on this posting? I'm pleased I discovered it though, ill be checking back soon to find out what additional posts you include. smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel Thanks for posting this info. I just want to let you know that I just check out your site and I find it very interesting and informative. I can't wait to read lots of your posts.
  3. M. Shahid | Jul 06, 2020
    It was wondering if I could use this write-up on my other website, I will link it back to your website though.Great Thanks. Web Development Courses
  4. rogerlagasca | Jul 03, 2020
  5. rogerlagasca | Jul 02, 2020
  6. rogerlagasca | Jul 01, 2020

    Leave a comment

    Client Alert

    FDA Reverses Course on COVID-19 Antibody Tests, Will Now Require Review and Approval

    May 6, 2020, 12:19 PM
    Publication Type(s):
    Client Alerts
    Exlcude on home page:
    No

    On May 4, 2020, the U.S. Food and Drug Administration (“FDA”) announced new restrictions on the marketing and distribution of serology tests used to identify antibodies to COVID-19 during the course of the public health emergency. Such tests, which can quickly indicate whether someone has been exposed to a particular pathogen, such as COVID-19, could prove critical in determining the level of population that has been exposed to the virus and has potentially developed immunity to further infection.

    In an effort to allow valid tests to quickly become available, since mid-March, FDA had allowed for the manufacture and distribution of such tests without specific FDA approval, so long as the manufacturer (i) notified FDA of its intent to distribute the tests, (ii) affirmed that the tests were validated, and (iii) provided instructions for use containing required disclaimers, including that the test had not been reviewed by FDA and should not be used as the sole basis to diagnose an infection. However, since the publication of that policy, significant questions were raised about the validity and proper use of at least some tests being marketed.

    In response, FDA published the new restrictions, outlined in FDA’s Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (revised May 4, 2020). The revisions make significant changes to the agency’s policy on COVID-19 antibody tests. Under the new guidance, FDA will now require the manufacturer or distributor to submit an Emergency Use Authorization (“EUA”) request and FDA will independently verify the manufacturer’s validation data. The new policy still allows for the distribution of validated tests prior to receiving an EUA, but companies must now prepare and submit an EUA within approximately 10 business days of distributing the tests. To help facilitate the process, FDA has developed an EUA template that is specific to such serology tests. If FDA identifies any concerns while reviewing an EUA submission, the agency has committed to providing companies with an opportunity to address any issues before initiating an enforcement action. If the manufacturer fails to file an EUA request within approximately 10 business days of beginning distribution, distribution is no longer authorized and must cease.

    In addition to approving EUAs for individual tests, FDA has also issued an umbrella EUA for all antibody tests that have been independently validated by the National Institutes of Health’s National Cancer Institute or any other agency that FDA has designated to conduct such validation. Companies may voluntarily submit their test to the National Cancer Institute for independent validation and, if deemed eligible by FDA, may request that their test be added to the umbrella EUA. The National Cancer Institute has so far conducted validation testing on 13 antibody tests but has not yet released the data publicly.

    Companies seeking to manufacture and distribute COVID-19 antibody tests are advised to engage FDA for a pre-EUA review early in the development process and should consider submitting their tests to the National Cancer Institute for independent validation. Companies who do so will be asked to sign a transfer agreement allowing that the test results be made publicly available. As of this writing, FDA has approved EUAs for 12 antibody tests and is currently reviewing submissions for an additional 200 tests. Distributors and consumers of antibody tests are advised to consult FDA’s website to ensure they are purchasing tests that have been properly validated. Those antibody tests that have received EUAs may be found on FDA’s website: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd.

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    6 comments

    Leave a comment
    1. rogerlagasca | Jul 06, 2020
      Excellent website you have here, so much cool information!.. managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา Hi! Thanks for the great information you havr provided! You have touched on crucuial points!
    2. rogerlagasca | Jul 06, 2020
      Positive site, where did u come up with the information on this posting? I'm pleased I discovered it though, ill be checking back soon to find out what additional posts you include. smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel Thanks for posting this info. I just want to let you know that I just check out your site and I find it very interesting and informative. I can't wait to read lots of your posts.
    3. M. Shahid | Jul 06, 2020
      It was wondering if I could use this write-up on my other website, I will link it back to your website though.Great Thanks. Web Development Courses
    4. rogerlagasca | Jul 03, 2020
    5. rogerlagasca | Jul 02, 2020
    6. rogerlagasca | Jul 01, 2020

      Leave a comment

      LABOR & EMPLOYMENT

      FDA Reverses Course on COVID-19 Antibody Tests, Will Now Require Review and Approval

      May 6, 2020, 12:19 PM
      Publication Type(s):
      Client Alerts
      Exlcude on home page:
      No

      On May 4, 2020, the U.S. Food and Drug Administration (“FDA”) announced new restrictions on the marketing and distribution of serology tests used to identify antibodies to COVID-19 during the course of the public health emergency. Such tests, which can quickly indicate whether someone has been exposed to a particular pathogen, such as COVID-19, could prove critical in determining the level of population that has been exposed to the virus and has potentially developed immunity to further infection.

      In an effort to allow valid tests to quickly become available, since mid-March, FDA had allowed for the manufacture and distribution of such tests without specific FDA approval, so long as the manufacturer (i) notified FDA of its intent to distribute the tests, (ii) affirmed that the tests were validated, and (iii) provided instructions for use containing required disclaimers, including that the test had not been reviewed by FDA and should not be used as the sole basis to diagnose an infection. However, since the publication of that policy, significant questions were raised about the validity and proper use of at least some tests being marketed.

      In response, FDA published the new restrictions, outlined in FDA’s Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (revised May 4, 2020). The revisions make significant changes to the agency’s policy on COVID-19 antibody tests. Under the new guidance, FDA will now require the manufacturer or distributor to submit an Emergency Use Authorization (“EUA”) request and FDA will independently verify the manufacturer’s validation data. The new policy still allows for the distribution of validated tests prior to receiving an EUA, but companies must now prepare and submit an EUA within approximately 10 business days of distributing the tests. To help facilitate the process, FDA has developed an EUA template that is specific to such serology tests. If FDA identifies any concerns while reviewing an EUA submission, the agency has committed to providing companies with an opportunity to address any issues before initiating an enforcement action. If the manufacturer fails to file an EUA request within approximately 10 business days of beginning distribution, distribution is no longer authorized and must cease.

      In addition to approving EUAs for individual tests, FDA has also issued an umbrella EUA for all antibody tests that have been independently validated by the National Institutes of Health’s National Cancer Institute or any other agency that FDA has designated to conduct such validation. Companies may voluntarily submit their test to the National Cancer Institute for independent validation and, if deemed eligible by FDA, may request that their test be added to the umbrella EUA. The National Cancer Institute has so far conducted validation testing on 13 antibody tests but has not yet released the data publicly.

      Companies seeking to manufacture and distribute COVID-19 antibody tests are advised to engage FDA for a pre-EUA review early in the development process and should consider submitting their tests to the National Cancer Institute for independent validation. Companies who do so will be asked to sign a transfer agreement allowing that the test results be made publicly available. As of this writing, FDA has approved EUAs for 12 antibody tests and is currently reviewing submissions for an additional 200 tests. Distributors and consumers of antibody tests are advised to consult FDA’s website to ensure they are purchasing tests that have been properly validated. Those antibody tests that have received EUAs may be found on FDA’s website: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd.

      IsRss:
      • client alerts

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      Linked PracticeAreas

      6 comments

      Leave a comment
      1. rogerlagasca | Jul 06, 2020
        Excellent website you have here, so much cool information!.. managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา Hi! Thanks for the great information you havr provided! You have touched on crucuial points!
      2. rogerlagasca | Jul 06, 2020
        Positive site, where did u come up with the information on this posting? I'm pleased I discovered it though, ill be checking back soon to find out what additional posts you include. smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel Thanks for posting this info. I just want to let you know that I just check out your site and I find it very interesting and informative. I can't wait to read lots of your posts.
      3. M. Shahid | Jul 06, 2020
        It was wondering if I could use this write-up on my other website, I will link it back to your website though.Great Thanks. Web Development Courses
      4. rogerlagasca | Jul 03, 2020
      5. rogerlagasca | Jul 02, 2020
      6. rogerlagasca | Jul 01, 2020

        Leave a comment

        FINANCIAL REGULATION & THE CARES ACT

        FDA Reverses Course on COVID-19 Antibody Tests, Will Now Require Review and Approval

        May 6, 2020, 12:19 PM
        Publication Type(s):
        Client Alerts
        Exlcude on home page:
        No

        On May 4, 2020, the U.S. Food and Drug Administration (“FDA”) announced new restrictions on the marketing and distribution of serology tests used to identify antibodies to COVID-19 during the course of the public health emergency. Such tests, which can quickly indicate whether someone has been exposed to a particular pathogen, such as COVID-19, could prove critical in determining the level of population that has been exposed to the virus and has potentially developed immunity to further infection.

        In an effort to allow valid tests to quickly become available, since mid-March, FDA had allowed for the manufacture and distribution of such tests without specific FDA approval, so long as the manufacturer (i) notified FDA of its intent to distribute the tests, (ii) affirmed that the tests were validated, and (iii) provided instructions for use containing required disclaimers, including that the test had not been reviewed by FDA and should not be used as the sole basis to diagnose an infection. However, since the publication of that policy, significant questions were raised about the validity and proper use of at least some tests being marketed.

        In response, FDA published the new restrictions, outlined in FDA’s Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (revised May 4, 2020). The revisions make significant changes to the agency’s policy on COVID-19 antibody tests. Under the new guidance, FDA will now require the manufacturer or distributor to submit an Emergency Use Authorization (“EUA”) request and FDA will independently verify the manufacturer’s validation data. The new policy still allows for the distribution of validated tests prior to receiving an EUA, but companies must now prepare and submit an EUA within approximately 10 business days of distributing the tests. To help facilitate the process, FDA has developed an EUA template that is specific to such serology tests. If FDA identifies any concerns while reviewing an EUA submission, the agency has committed to providing companies with an opportunity to address any issues before initiating an enforcement action. If the manufacturer fails to file an EUA request within approximately 10 business days of beginning distribution, distribution is no longer authorized and must cease.

        In addition to approving EUAs for individual tests, FDA has also issued an umbrella EUA for all antibody tests that have been independently validated by the National Institutes of Health’s National Cancer Institute or any other agency that FDA has designated to conduct such validation. Companies may voluntarily submit their test to the National Cancer Institute for independent validation and, if deemed eligible by FDA, may request that their test be added to the umbrella EUA. The National Cancer Institute has so far conducted validation testing on 13 antibody tests but has not yet released the data publicly.

        Companies seeking to manufacture and distribute COVID-19 antibody tests are advised to engage FDA for a pre-EUA review early in the development process and should consider submitting their tests to the National Cancer Institute for independent validation. Companies who do so will be asked to sign a transfer agreement allowing that the test results be made publicly available. As of this writing, FDA has approved EUAs for 12 antibody tests and is currently reviewing submissions for an additional 200 tests. Distributors and consumers of antibody tests are advised to consult FDA’s website to ensure they are purchasing tests that have been properly validated. Those antibody tests that have received EUAs may be found on FDA’s website: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd.

        IsRss:
        • client alerts

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        6 comments

        Leave a comment
        1. rogerlagasca | Jul 06, 2020
          Excellent website you have here, so much cool information!.. managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา Hi! Thanks for the great information you havr provided! You have touched on crucuial points!
        2. rogerlagasca | Jul 06, 2020
          Positive site, where did u come up with the information on this posting? I'm pleased I discovered it though, ill be checking back soon to find out what additional posts you include. smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel Thanks for posting this info. I just want to let you know that I just check out your site and I find it very interesting and informative. I can't wait to read lots of your posts.
        3. M. Shahid | Jul 06, 2020
          It was wondering if I could use this write-up on my other website, I will link it back to your website though.Great Thanks. Web Development Courses
        4. rogerlagasca | Jul 03, 2020
        5. rogerlagasca | Jul 02, 2020
        6. rogerlagasca | Jul 01, 2020

          Leave a comment

          ASSET MANAGEMENT

          FDA Reverses Course on COVID-19 Antibody Tests, Will Now Require Review and Approval

          May 6, 2020, 12:19 PM
          Publication Type(s):
          Client Alerts
          Exlcude on home page:
          No

          On May 4, 2020, the U.S. Food and Drug Administration (“FDA”) announced new restrictions on the marketing and distribution of serology tests used to identify antibodies to COVID-19 during the course of the public health emergency. Such tests, which can quickly indicate whether someone has been exposed to a particular pathogen, such as COVID-19, could prove critical in determining the level of population that has been exposed to the virus and has potentially developed immunity to further infection.

          In an effort to allow valid tests to quickly become available, since mid-March, FDA had allowed for the manufacture and distribution of such tests without specific FDA approval, so long as the manufacturer (i) notified FDA of its intent to distribute the tests, (ii) affirmed that the tests were validated, and (iii) provided instructions for use containing required disclaimers, including that the test had not been reviewed by FDA and should not be used as the sole basis to diagnose an infection. However, since the publication of that policy, significant questions were raised about the validity and proper use of at least some tests being marketed.

          In response, FDA published the new restrictions, outlined in FDA’s Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (revised May 4, 2020). The revisions make significant changes to the agency’s policy on COVID-19 antibody tests. Under the new guidance, FDA will now require the manufacturer or distributor to submit an Emergency Use Authorization (“EUA”) request and FDA will independently verify the manufacturer’s validation data. The new policy still allows for the distribution of validated tests prior to receiving an EUA, but companies must now prepare and submit an EUA within approximately 10 business days of distributing the tests. To help facilitate the process, FDA has developed an EUA template that is specific to such serology tests. If FDA identifies any concerns while reviewing an EUA submission, the agency has committed to providing companies with an opportunity to address any issues before initiating an enforcement action. If the manufacturer fails to file an EUA request within approximately 10 business days of beginning distribution, distribution is no longer authorized and must cease.

          In addition to approving EUAs for individual tests, FDA has also issued an umbrella EUA for all antibody tests that have been independently validated by the National Institutes of Health’s National Cancer Institute or any other agency that FDA has designated to conduct such validation. Companies may voluntarily submit their test to the National Cancer Institute for independent validation and, if deemed eligible by FDA, may request that their test be added to the umbrella EUA. The National Cancer Institute has so far conducted validation testing on 13 antibody tests but has not yet released the data publicly.

          Companies seeking to manufacture and distribute COVID-19 antibody tests are advised to engage FDA for a pre-EUA review early in the development process and should consider submitting their tests to the National Cancer Institute for independent validation. Companies who do so will be asked to sign a transfer agreement allowing that the test results be made publicly available. As of this writing, FDA has approved EUAs for 12 antibody tests and is currently reviewing submissions for an additional 200 tests. Distributors and consumers of antibody tests are advised to consult FDA’s website to ensure they are purchasing tests that have been properly validated. Those antibody tests that have received EUAs may be found on FDA’s website: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd.

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          • client alerts

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          Linked PracticeAreas

          6 comments

          Leave a comment
          1. rogerlagasca | Jul 06, 2020
            Excellent website you have here, so much cool information!.. managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา Hi! Thanks for the great information you havr provided! You have touched on crucuial points!
          2. rogerlagasca | Jul 06, 2020
            Positive site, where did u come up with the information on this posting? I'm pleased I discovered it though, ill be checking back soon to find out what additional posts you include. smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel Thanks for posting this info. I just want to let you know that I just check out your site and I find it very interesting and informative. I can't wait to read lots of your posts.
          3. M. Shahid | Jul 06, 2020
            It was wondering if I could use this write-up on my other website, I will link it back to your website though.Great Thanks. Web Development Courses
          4. rogerlagasca | Jul 03, 2020
          5. rogerlagasca | Jul 02, 2020
          6. rogerlagasca | Jul 01, 2020

            Leave a comment

            TAX LAW

            FDA Reverses Course on COVID-19 Antibody Tests, Will Now Require Review and Approval

            May 6, 2020, 12:19 PM
            Publication Type(s):
            Client Alerts
            Exlcude on home page:
            No

            On May 4, 2020, the U.S. Food and Drug Administration (“FDA”) announced new restrictions on the marketing and distribution of serology tests used to identify antibodies to COVID-19 during the course of the public health emergency. Such tests, which can quickly indicate whether someone has been exposed to a particular pathogen, such as COVID-19, could prove critical in determining the level of population that has been exposed to the virus and has potentially developed immunity to further infection.

            In an effort to allow valid tests to quickly become available, since mid-March, FDA had allowed for the manufacture and distribution of such tests without specific FDA approval, so long as the manufacturer (i) notified FDA of its intent to distribute the tests, (ii) affirmed that the tests were validated, and (iii) provided instructions for use containing required disclaimers, including that the test had not been reviewed by FDA and should not be used as the sole basis to diagnose an infection. However, since the publication of that policy, significant questions were raised about the validity and proper use of at least some tests being marketed.

            In response, FDA published the new restrictions, outlined in FDA’s Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (revised May 4, 2020). The revisions make significant changes to the agency’s policy on COVID-19 antibody tests. Under the new guidance, FDA will now require the manufacturer or distributor to submit an Emergency Use Authorization (“EUA”) request and FDA will independently verify the manufacturer’s validation data. The new policy still allows for the distribution of validated tests prior to receiving an EUA, but companies must now prepare and submit an EUA within approximately 10 business days of distributing the tests. To help facilitate the process, FDA has developed an EUA template that is specific to such serology tests. If FDA identifies any concerns while reviewing an EUA submission, the agency has committed to providing companies with an opportunity to address any issues before initiating an enforcement action. If the manufacturer fails to file an EUA request within approximately 10 business days of beginning distribution, distribution is no longer authorized and must cease.

            In addition to approving EUAs for individual tests, FDA has also issued an umbrella EUA for all antibody tests that have been independently validated by the National Institutes of Health’s National Cancer Institute or any other agency that FDA has designated to conduct such validation. Companies may voluntarily submit their test to the National Cancer Institute for independent validation and, if deemed eligible by FDA, may request that their test be added to the umbrella EUA. The National Cancer Institute has so far conducted validation testing on 13 antibody tests but has not yet released the data publicly.

            Companies seeking to manufacture and distribute COVID-19 antibody tests are advised to engage FDA for a pre-EUA review early in the development process and should consider submitting their tests to the National Cancer Institute for independent validation. Companies who do so will be asked to sign a transfer agreement allowing that the test results be made publicly available. As of this writing, FDA has approved EUAs for 12 antibody tests and is currently reviewing submissions for an additional 200 tests. Distributors and consumers of antibody tests are advised to consult FDA’s website to ensure they are purchasing tests that have been properly validated. Those antibody tests that have received EUAs may be found on FDA’s website: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd.

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            1. rogerlagasca | Jul 06, 2020
              Excellent website you have here, so much cool information!.. managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา Hi! Thanks for the great information you havr provided! You have touched on crucuial points!
            2. rogerlagasca | Jul 06, 2020
              Positive site, where did u come up with the information on this posting? I'm pleased I discovered it though, ill be checking back soon to find out what additional posts you include. smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel Thanks for posting this info. I just want to let you know that I just check out your site and I find it very interesting and informative. I can't wait to read lots of your posts.
            3. M. Shahid | Jul 06, 2020
              It was wondering if I could use this write-up on my other website, I will link it back to your website though.Great Thanks. Web Development Courses
            4. rogerlagasca | Jul 03, 2020
            5. rogerlagasca | Jul 02, 2020
            6. rogerlagasca | Jul 01, 2020

              Leave a comment

              REAL ESTATE & HOSPITALITY

              FDA Reverses Course on COVID-19 Antibody Tests, Will Now Require Review and Approval

              May 6, 2020, 12:19 PM
              Publication Type(s):
              Client Alerts
              Exlcude on home page:
              No

              On May 4, 2020, the U.S. Food and Drug Administration (“FDA”) announced new restrictions on the marketing and distribution of serology tests used to identify antibodies to COVID-19 during the course of the public health emergency. Such tests, which can quickly indicate whether someone has been exposed to a particular pathogen, such as COVID-19, could prove critical in determining the level of population that has been exposed to the virus and has potentially developed immunity to further infection.

              In an effort to allow valid tests to quickly become available, since mid-March, FDA had allowed for the manufacture and distribution of such tests without specific FDA approval, so long as the manufacturer (i) notified FDA of its intent to distribute the tests, (ii) affirmed that the tests were validated, and (iii) provided instructions for use containing required disclaimers, including that the test had not been reviewed by FDA and should not be used as the sole basis to diagnose an infection. However, since the publication of that policy, significant questions were raised about the validity and proper use of at least some tests being marketed.

              In response, FDA published the new restrictions, outlined in FDA’s Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (revised May 4, 2020). The revisions make significant changes to the agency’s policy on COVID-19 antibody tests. Under the new guidance, FDA will now require the manufacturer or distributor to submit an Emergency Use Authorization (“EUA”) request and FDA will independently verify the manufacturer’s validation data. The new policy still allows for the distribution of validated tests prior to receiving an EUA, but companies must now prepare and submit an EUA within approximately 10 business days of distributing the tests. To help facilitate the process, FDA has developed an EUA template that is specific to such serology tests. If FDA identifies any concerns while reviewing an EUA submission, the agency has committed to providing companies with an opportunity to address any issues before initiating an enforcement action. If the manufacturer fails to file an EUA request within approximately 10 business days of beginning distribution, distribution is no longer authorized and must cease.

              In addition to approving EUAs for individual tests, FDA has also issued an umbrella EUA for all antibody tests that have been independently validated by the National Institutes of Health’s National Cancer Institute or any other agency that FDA has designated to conduct such validation. Companies may voluntarily submit their test to the National Cancer Institute for independent validation and, if deemed eligible by FDA, may request that their test be added to the umbrella EUA. The National Cancer Institute has so far conducted validation testing on 13 antibody tests but has not yet released the data publicly.

              Companies seeking to manufacture and distribute COVID-19 antibody tests are advised to engage FDA for a pre-EUA review early in the development process and should consider submitting their tests to the National Cancer Institute for independent validation. Companies who do so will be asked to sign a transfer agreement allowing that the test results be made publicly available. As of this writing, FDA has approved EUAs for 12 antibody tests and is currently reviewing submissions for an additional 200 tests. Distributors and consumers of antibody tests are advised to consult FDA’s website to ensure they are purchasing tests that have been properly validated. Those antibody tests that have received EUAs may be found on FDA’s website: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd.

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              1. rogerlagasca | Jul 06, 2020
                Excellent website you have here, so much cool information!.. managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา Hi! Thanks for the great information you havr provided! You have touched on crucuial points!
              2. rogerlagasca | Jul 06, 2020
                Positive site, where did u come up with the information on this posting? I'm pleased I discovered it though, ill be checking back soon to find out what additional posts you include. smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel Thanks for posting this info. I just want to let you know that I just check out your site and I find it very interesting and informative. I can't wait to read lots of your posts.
              3. M. Shahid | Jul 06, 2020
                It was wondering if I could use this write-up on my other website, I will link it back to your website though.Great Thanks. Web Development Courses
              4. rogerlagasca | Jul 03, 2020
              5. rogerlagasca | Jul 02, 2020
              6. rogerlagasca | Jul 01, 2020

                Leave a comment

                DISPUTES

                FDA Reverses Course on COVID-19 Antibody Tests, Will Now Require Review and Approval

                May 6, 2020, 12:19 PM
                Publication Type(s):
                Client Alerts
                Exlcude on home page:
                No

                On May 4, 2020, the U.S. Food and Drug Administration (“FDA”) announced new restrictions on the marketing and distribution of serology tests used to identify antibodies to COVID-19 during the course of the public health emergency. Such tests, which can quickly indicate whether someone has been exposed to a particular pathogen, such as COVID-19, could prove critical in determining the level of population that has been exposed to the virus and has potentially developed immunity to further infection.

                In an effort to allow valid tests to quickly become available, since mid-March, FDA had allowed for the manufacture and distribution of such tests without specific FDA approval, so long as the manufacturer (i) notified FDA of its intent to distribute the tests, (ii) affirmed that the tests were validated, and (iii) provided instructions for use containing required disclaimers, including that the test had not been reviewed by FDA and should not be used as the sole basis to diagnose an infection. However, since the publication of that policy, significant questions were raised about the validity and proper use of at least some tests being marketed.

                In response, FDA published the new restrictions, outlined in FDA’s Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (revised May 4, 2020). The revisions make significant changes to the agency’s policy on COVID-19 antibody tests. Under the new guidance, FDA will now require the manufacturer or distributor to submit an Emergency Use Authorization (“EUA”) request and FDA will independently verify the manufacturer’s validation data. The new policy still allows for the distribution of validated tests prior to receiving an EUA, but companies must now prepare and submit an EUA within approximately 10 business days of distributing the tests. To help facilitate the process, FDA has developed an EUA template that is specific to such serology tests. If FDA identifies any concerns while reviewing an EUA submission, the agency has committed to providing companies with an opportunity to address any issues before initiating an enforcement action. If the manufacturer fails to file an EUA request within approximately 10 business days of beginning distribution, distribution is no longer authorized and must cease.

                In addition to approving EUAs for individual tests, FDA has also issued an umbrella EUA for all antibody tests that have been independently validated by the National Institutes of Health’s National Cancer Institute or any other agency that FDA has designated to conduct such validation. Companies may voluntarily submit their test to the National Cancer Institute for independent validation and, if deemed eligible by FDA, may request that their test be added to the umbrella EUA. The National Cancer Institute has so far conducted validation testing on 13 antibody tests but has not yet released the data publicly.

                Companies seeking to manufacture and distribute COVID-19 antibody tests are advised to engage FDA for a pre-EUA review early in the development process and should consider submitting their tests to the National Cancer Institute for independent validation. Companies who do so will be asked to sign a transfer agreement allowing that the test results be made publicly available. As of this writing, FDA has approved EUAs for 12 antibody tests and is currently reviewing submissions for an additional 200 tests. Distributors and consumers of antibody tests are advised to consult FDA’s website to ensure they are purchasing tests that have been properly validated. Those antibody tests that have received EUAs may be found on FDA’s website: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd.

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                Leave a comment
                1. rogerlagasca | Jul 06, 2020
                  Excellent website you have here, so much cool information!.. managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา Hi! Thanks for the great information you havr provided! You have touched on crucuial points!
                2. rogerlagasca | Jul 06, 2020
                  Positive site, where did u come up with the information on this posting? I'm pleased I discovered it though, ill be checking back soon to find out what additional posts you include. smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel Thanks for posting this info. I just want to let you know that I just check out your site and I find it very interesting and informative. I can't wait to read lots of your posts.
                3. M. Shahid | Jul 06, 2020
                  It was wondering if I could use this write-up on my other website, I will link it back to your website though.Great Thanks. Web Development Courses
                4. rogerlagasca | Jul 03, 2020
                5. rogerlagasca | Jul 02, 2020
                6. rogerlagasca | Jul 01, 2020

                  Leave a comment

                  PRIVACY & CYBERSECURITY

                  FDA Reverses Course on COVID-19 Antibody Tests, Will Now Require Review and Approval

                  May 6, 2020, 12:19 PM
                  Publication Type(s):
                  Client Alerts
                  Exlcude on home page:
                  No

                  On May 4, 2020, the U.S. Food and Drug Administration (“FDA”) announced new restrictions on the marketing and distribution of serology tests used to identify antibodies to COVID-19 during the course of the public health emergency. Such tests, which can quickly indicate whether someone has been exposed to a particular pathogen, such as COVID-19, could prove critical in determining the level of population that has been exposed to the virus and has potentially developed immunity to further infection.

                  In an effort to allow valid tests to quickly become available, since mid-March, FDA had allowed for the manufacture and distribution of such tests without specific FDA approval, so long as the manufacturer (i) notified FDA of its intent to distribute the tests, (ii) affirmed that the tests were validated, and (iii) provided instructions for use containing required disclaimers, including that the test had not been reviewed by FDA and should not be used as the sole basis to diagnose an infection. However, since the publication of that policy, significant questions were raised about the validity and proper use of at least some tests being marketed.

                  In response, FDA published the new restrictions, outlined in FDA’s Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (revised May 4, 2020). The revisions make significant changes to the agency’s policy on COVID-19 antibody tests. Under the new guidance, FDA will now require the manufacturer or distributor to submit an Emergency Use Authorization (“EUA”) request and FDA will independently verify the manufacturer’s validation data. The new policy still allows for the distribution of validated tests prior to receiving an EUA, but companies must now prepare and submit an EUA within approximately 10 business days of distributing the tests. To help facilitate the process, FDA has developed an EUA template that is specific to such serology tests. If FDA identifies any concerns while reviewing an EUA submission, the agency has committed to providing companies with an opportunity to address any issues before initiating an enforcement action. If the manufacturer fails to file an EUA request within approximately 10 business days of beginning distribution, distribution is no longer authorized and must cease.

                  In addition to approving EUAs for individual tests, FDA has also issued an umbrella EUA for all antibody tests that have been independently validated by the National Institutes of Health’s National Cancer Institute or any other agency that FDA has designated to conduct such validation. Companies may voluntarily submit their test to the National Cancer Institute for independent validation and, if deemed eligible by FDA, may request that their test be added to the umbrella EUA. The National Cancer Institute has so far conducted validation testing on 13 antibody tests but has not yet released the data publicly.

                  Companies seeking to manufacture and distribute COVID-19 antibody tests are advised to engage FDA for a pre-EUA review early in the development process and should consider submitting their tests to the National Cancer Institute for independent validation. Companies who do so will be asked to sign a transfer agreement allowing that the test results be made publicly available. As of this writing, FDA has approved EUAs for 12 antibody tests and is currently reviewing submissions for an additional 200 tests. Distributors and consumers of antibody tests are advised to consult FDA’s website to ensure they are purchasing tests that have been properly validated. Those antibody tests that have received EUAs may be found on FDA’s website: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd.

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                  6 comments

                  Leave a comment
                  1. rogerlagasca | Jul 06, 2020
                    Excellent website you have here, so much cool information!.. managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา Hi! Thanks for the great information you havr provided! You have touched on crucuial points!
                  2. rogerlagasca | Jul 06, 2020
                    Positive site, where did u come up with the information on this posting? I'm pleased I discovered it though, ill be checking back soon to find out what additional posts you include. smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel Thanks for posting this info. I just want to let you know that I just check out your site and I find it very interesting and informative. I can't wait to read lots of your posts.
                  3. M. Shahid | Jul 06, 2020
                    It was wondering if I could use this write-up on my other website, I will link it back to your website though.Great Thanks. Web Development Courses
                  4. rogerlagasca | Jul 03, 2020
                  5. rogerlagasca | Jul 02, 2020
                  6. rogerlagasca | Jul 01, 2020

                    Leave a comment

                    SECURITIES & CAPITAL MARKETS

                    FDA Reverses Course on COVID-19 Antibody Tests, Will Now Require Review and Approval

                    May 6, 2020, 12:19 PM
                    Publication Type(s):
                    Client Alerts
                    Exlcude on home page:
                    No

                    On May 4, 2020, the U.S. Food and Drug Administration (“FDA”) announced new restrictions on the marketing and distribution of serology tests used to identify antibodies to COVID-19 during the course of the public health emergency. Such tests, which can quickly indicate whether someone has been exposed to a particular pathogen, such as COVID-19, could prove critical in determining the level of population that has been exposed to the virus and has potentially developed immunity to further infection.

                    In an effort to allow valid tests to quickly become available, since mid-March, FDA had allowed for the manufacture and distribution of such tests without specific FDA approval, so long as the manufacturer (i) notified FDA of its intent to distribute the tests, (ii) affirmed that the tests were validated, and (iii) provided instructions for use containing required disclaimers, including that the test had not been reviewed by FDA and should not be used as the sole basis to diagnose an infection. However, since the publication of that policy, significant questions were raised about the validity and proper use of at least some tests being marketed.

                    In response, FDA published the new restrictions, outlined in FDA’s Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (revised May 4, 2020). The revisions make significant changes to the agency’s policy on COVID-19 antibody tests. Under the new guidance, FDA will now require the manufacturer or distributor to submit an Emergency Use Authorization (“EUA”) request and FDA will independently verify the manufacturer’s validation data. The new policy still allows for the distribution of validated tests prior to receiving an EUA, but companies must now prepare and submit an EUA within approximately 10 business days of distributing the tests. To help facilitate the process, FDA has developed an EUA template that is specific to such serology tests. If FDA identifies any concerns while reviewing an EUA submission, the agency has committed to providing companies with an opportunity to address any issues before initiating an enforcement action. If the manufacturer fails to file an EUA request within approximately 10 business days of beginning distribution, distribution is no longer authorized and must cease.

                    In addition to approving EUAs for individual tests, FDA has also issued an umbrella EUA for all antibody tests that have been independently validated by the National Institutes of Health’s National Cancer Institute or any other agency that FDA has designated to conduct such validation. Companies may voluntarily submit their test to the National Cancer Institute for independent validation and, if deemed eligible by FDA, may request that their test be added to the umbrella EUA. The National Cancer Institute has so far conducted validation testing on 13 antibody tests but has not yet released the data publicly.

                    Companies seeking to manufacture and distribute COVID-19 antibody tests are advised to engage FDA for a pre-EUA review early in the development process and should consider submitting their tests to the National Cancer Institute for independent validation. Companies who do so will be asked to sign a transfer agreement allowing that the test results be made publicly available. As of this writing, FDA has approved EUAs for 12 antibody tests and is currently reviewing submissions for an additional 200 tests. Distributors and consumers of antibody tests are advised to consult FDA’s website to ensure they are purchasing tests that have been properly validated. Those antibody tests that have received EUAs may be found on FDA’s website: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd.

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                    Leave a comment
                    1. rogerlagasca | Jul 06, 2020
                      Excellent website you have here, so much cool information!.. managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา Hi! Thanks for the great information you havr provided! You have touched on crucuial points!
                    2. rogerlagasca | Jul 06, 2020
                      Positive site, where did u come up with the information on this posting? I'm pleased I discovered it though, ill be checking back soon to find out what additional posts you include. smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel Thanks for posting this info. I just want to let you know that I just check out your site and I find it very interesting and informative. I can't wait to read lots of your posts.
                    3. M. Shahid | Jul 06, 2020
                      It was wondering if I could use this write-up on my other website, I will link it back to your website though.Great Thanks. Web Development Courses
                    4. rogerlagasca | Jul 03, 2020
                    5. rogerlagasca | Jul 02, 2020
                    6. rogerlagasca | Jul 01, 2020

                      Leave a comment

                      EUROPE

                      FDA Reverses Course on COVID-19 Antibody Tests, Will Now Require Review and Approval

                      May 6, 2020, 12:19 PM
                      Publication Type(s):
                      Client Alerts
                      Exlcude on home page:
                      No

                      On May 4, 2020, the U.S. Food and Drug Administration (“FDA”) announced new restrictions on the marketing and distribution of serology tests used to identify antibodies to COVID-19 during the course of the public health emergency. Such tests, which can quickly indicate whether someone has been exposed to a particular pathogen, such as COVID-19, could prove critical in determining the level of population that has been exposed to the virus and has potentially developed immunity to further infection.

                      In an effort to allow valid tests to quickly become available, since mid-March, FDA had allowed for the manufacture and distribution of such tests without specific FDA approval, so long as the manufacturer (i) notified FDA of its intent to distribute the tests, (ii) affirmed that the tests were validated, and (iii) provided instructions for use containing required disclaimers, including that the test had not been reviewed by FDA and should not be used as the sole basis to diagnose an infection. However, since the publication of that policy, significant questions were raised about the validity and proper use of at least some tests being marketed.

                      In response, FDA published the new restrictions, outlined in FDA’s Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (revised May 4, 2020). The revisions make significant changes to the agency’s policy on COVID-19 antibody tests. Under the new guidance, FDA will now require the manufacturer or distributor to submit an Emergency Use Authorization (“EUA”) request and FDA will independently verify the manufacturer’s validation data. The new policy still allows for the distribution of validated tests prior to receiving an EUA, but companies must now prepare and submit an EUA within approximately 10 business days of distributing the tests. To help facilitate the process, FDA has developed an EUA template that is specific to such serology tests. If FDA identifies any concerns while reviewing an EUA submission, the agency has committed to providing companies with an opportunity to address any issues before initiating an enforcement action. If the manufacturer fails to file an EUA request within approximately 10 business days of beginning distribution, distribution is no longer authorized and must cease.

                      In addition to approving EUAs for individual tests, FDA has also issued an umbrella EUA for all antibody tests that have been independently validated by the National Institutes of Health’s National Cancer Institute or any other agency that FDA has designated to conduct such validation. Companies may voluntarily submit their test to the National Cancer Institute for independent validation and, if deemed eligible by FDA, may request that their test be added to the umbrella EUA. The National Cancer Institute has so far conducted validation testing on 13 antibody tests but has not yet released the data publicly.

                      Companies seeking to manufacture and distribute COVID-19 antibody tests are advised to engage FDA for a pre-EUA review early in the development process and should consider submitting their tests to the National Cancer Institute for independent validation. Companies who do so will be asked to sign a transfer agreement allowing that the test results be made publicly available. As of this writing, FDA has approved EUAs for 12 antibody tests and is currently reviewing submissions for an additional 200 tests. Distributors and consumers of antibody tests are advised to consult FDA’s website to ensure they are purchasing tests that have been properly validated. Those antibody tests that have received EUAs may be found on FDA’s website: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd.

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                      1. rogerlagasca | Jul 06, 2020
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                      2. rogerlagasca | Jul 06, 2020
                        Positive site, where did u come up with the information on this posting? I'm pleased I discovered it though, ill be checking back soon to find out what additional posts you include. smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel Thanks for posting this info. I just want to let you know that I just check out your site and I find it very interesting and informative. I can't wait to read lots of your posts.
                      3. M. Shahid | Jul 06, 2020
                        It was wondering if I could use this write-up on my other website, I will link it back to your website though.Great Thanks. Web Development Courses
                      4. rogerlagasca | Jul 03, 2020
                      5. rogerlagasca | Jul 02, 2020
                      6. rogerlagasca | Jul 01, 2020

                        Leave a comment

                        LATIN AMERICA

                        FDA Reverses Course on COVID-19 Antibody Tests, Will Now Require Review and Approval

                        May 6, 2020, 12:19 PM
                        Publication Type(s):
                        Client Alerts
                        Exlcude on home page:
                        No

                        On May 4, 2020, the U.S. Food and Drug Administration (“FDA”) announced new restrictions on the marketing and distribution of serology tests used to identify antibodies to COVID-19 during the course of the public health emergency. Such tests, which can quickly indicate whether someone has been exposed to a particular pathogen, such as COVID-19, could prove critical in determining the level of population that has been exposed to the virus and has potentially developed immunity to further infection.

                        In an effort to allow valid tests to quickly become available, since mid-March, FDA had allowed for the manufacture and distribution of such tests without specific FDA approval, so long as the manufacturer (i) notified FDA of its intent to distribute the tests, (ii) affirmed that the tests were validated, and (iii) provided instructions for use containing required disclaimers, including that the test had not been reviewed by FDA and should not be used as the sole basis to diagnose an infection. However, since the publication of that policy, significant questions were raised about the validity and proper use of at least some tests being marketed.

                        In response, FDA published the new restrictions, outlined in FDA’s Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (revised May 4, 2020). The revisions make significant changes to the agency’s policy on COVID-19 antibody tests. Under the new guidance, FDA will now require the manufacturer or distributor to submit an Emergency Use Authorization (“EUA”) request and FDA will independently verify the manufacturer’s validation data. The new policy still allows for the distribution of validated tests prior to receiving an EUA, but companies must now prepare and submit an EUA within approximately 10 business days of distributing the tests. To help facilitate the process, FDA has developed an EUA template that is specific to such serology tests. If FDA identifies any concerns while reviewing an EUA submission, the agency has committed to providing companies with an opportunity to address any issues before initiating an enforcement action. If the manufacturer fails to file an EUA request within approximately 10 business days of beginning distribution, distribution is no longer authorized and must cease.

                        In addition to approving EUAs for individual tests, FDA has also issued an umbrella EUA for all antibody tests that have been independently validated by the National Institutes of Health’s National Cancer Institute or any other agency that FDA has designated to conduct such validation. Companies may voluntarily submit their test to the National Cancer Institute for independent validation and, if deemed eligible by FDA, may request that their test be added to the umbrella EUA. The National Cancer Institute has so far conducted validation testing on 13 antibody tests but has not yet released the data publicly.

                        Companies seeking to manufacture and distribute COVID-19 antibody tests are advised to engage FDA for a pre-EUA review early in the development process and should consider submitting their tests to the National Cancer Institute for independent validation. Companies who do so will be asked to sign a transfer agreement allowing that the test results be made publicly available. As of this writing, FDA has approved EUAs for 12 antibody tests and is currently reviewing submissions for an additional 200 tests. Distributors and consumers of antibody tests are advised to consult FDA’s website to ensure they are purchasing tests that have been properly validated. Those antibody tests that have received EUAs may be found on FDA’s website: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd.

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                        6 comments

                        Leave a comment
                        1. rogerlagasca | Jul 06, 2020
                          Excellent website you have here, so much cool information!.. managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา Hi! Thanks for the great information you havr provided! You have touched on crucuial points!
                        2. rogerlagasca | Jul 06, 2020
                          Positive site, where did u come up with the information on this posting? I'm pleased I discovered it though, ill be checking back soon to find out what additional posts you include. smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel Thanks for posting this info. I just want to let you know that I just check out your site and I find it very interesting and informative. I can't wait to read lots of your posts.
                        3. M. Shahid | Jul 06, 2020
                          It was wondering if I could use this write-up on my other website, I will link it back to your website though.Great Thanks. Web Development Courses
                        4. rogerlagasca | Jul 03, 2020
                        5. rogerlagasca | Jul 02, 2020
                        6. rogerlagasca | Jul 01, 2020

                          Leave a comment

                           

                          KEY INSIGHTS

                          FDA Reverses Course on COVID-19 Antibody Tests, Will Now Require Review and Approval

                          May 6, 2020, 12:19 PM
                          Publication Type(s):
                          Client Alerts
                          Exlcude on home page:
                          No

                          On May 4, 2020, the U.S. Food and Drug Administration (“FDA”) announced new restrictions on the marketing and distribution of serology tests used to identify antibodies to COVID-19 during the course of the public health emergency. Such tests, which can quickly indicate whether someone has been exposed to a particular pathogen, such as COVID-19, could prove critical in determining the level of population that has been exposed to the virus and has potentially developed immunity to further infection.

                          In an effort to allow valid tests to quickly become available, since mid-March, FDA had allowed for the manufacture and distribution of such tests without specific FDA approval, so long as the manufacturer (i) notified FDA of its intent to distribute the tests, (ii) affirmed that the tests were validated, and (iii) provided instructions for use containing required disclaimers, including that the test had not been reviewed by FDA and should not be used as the sole basis to diagnose an infection. However, since the publication of that policy, significant questions were raised about the validity and proper use of at least some tests being marketed.

                          In response, FDA published the new restrictions, outlined in FDA’s Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (revised May 4, 2020). The revisions make significant changes to the agency’s policy on COVID-19 antibody tests. Under the new guidance, FDA will now require the manufacturer or distributor to submit an Emergency Use Authorization (“EUA”) request and FDA will independently verify the manufacturer’s validation data. The new policy still allows for the distribution of validated tests prior to receiving an EUA, but companies must now prepare and submit an EUA within approximately 10 business days of distributing the tests. To help facilitate the process, FDA has developed an EUA template that is specific to such serology tests. If FDA identifies any concerns while reviewing an EUA submission, the agency has committed to providing companies with an opportunity to address any issues before initiating an enforcement action. If the manufacturer fails to file an EUA request within approximately 10 business days of beginning distribution, distribution is no longer authorized and must cease.

                          In addition to approving EUAs for individual tests, FDA has also issued an umbrella EUA for all antibody tests that have been independently validated by the National Institutes of Health’s National Cancer Institute or any other agency that FDA has designated to conduct such validation. Companies may voluntarily submit their test to the National Cancer Institute for independent validation and, if deemed eligible by FDA, may request that their test be added to the umbrella EUA. The National Cancer Institute has so far conducted validation testing on 13 antibody tests but has not yet released the data publicly.

                          Companies seeking to manufacture and distribute COVID-19 antibody tests are advised to engage FDA for a pre-EUA review early in the development process and should consider submitting their tests to the National Cancer Institute for independent validation. Companies who do so will be asked to sign a transfer agreement allowing that the test results be made publicly available. As of this writing, FDA has approved EUAs for 12 antibody tests and is currently reviewing submissions for an additional 200 tests. Distributors and consumers of antibody tests are advised to consult FDA’s website to ensure they are purchasing tests that have been properly validated. Those antibody tests that have received EUAs may be found on FDA’s website: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd.

                          IsRss:
                          • client alerts

                          Related professionals

                          Linked PracticeAreas

                          6 comments

                          Leave a comment
                          1. rogerlagasca | Jul 06, 2020
                            Excellent website you have here, so much cool information!.. managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา managed it services torontoา Hi! Thanks for the great information you havr provided! You have touched on crucuial points!
                          2. rogerlagasca | Jul 06, 2020
                            Positive site, where did u come up with the information on this posting? I'm pleased I discovered it though, ill be checking back soon to find out what additional posts you include. smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel smm panel Thanks for posting this info. I just want to let you know that I just check out your site and I find it very interesting and informative. I can't wait to read lots of your posts.
                          3. M. Shahid | Jul 06, 2020
                            It was wondering if I could use this write-up on my other website, I will link it back to your website though.Great Thanks. Web Development Courses
                          4. rogerlagasca | Jul 03, 2020
                          5. rogerlagasca | Jul 02, 2020
                          6. rogerlagasca | Jul 01, 2020

                            Leave a comment

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