Life Sciences Regulatory

A client in successfully advocating to the FDA Exclusivity Board for favorable decision on the scope of three-year exclusivity.

A company in developing and implementing a strategy that convinced FDA to reverse its denial of orphan drug designation for the company’s sole product and moved the product to approval and orphan drug exclusivity.

Depomed at FDA and in court to obtain orphan exclusivity for Gralise.

Multiple clients on controlled substances compliance obligations, import/export provisions and quotas.

Multiple clients in DEA enforcement actions, including response to an order to show cause and negotiation of settlements.

Multiple companies in FDA dispute resolution and the Administrative Hearing process after FDA refusal to approve an NDA or BLA.

Multiple innovator companies in the negotiation, development and implementation of REMS.

Multiple pharmaceutical clients throughout the controlled substances scheduling process, leading to the successful marketing of the product.

Pharmaceutical clients in FDA pharmacovigilance inspections throughout the process, from preparation to successful closeout.

A senior executive in negotiating and operating under an FDA consent decree and subsequent Department of Justice investigation.

Strategic advisor to sponsors of products for rare diseases or high unmet need in the development of the data package for application submission and engagement with FDA before and during the review.