FDA Regulatory Practice


Our attorneys assist clients in determining whether there is a need to submit investigational new drug applications (INDs) and provide regulatory requirements related to INDs, new drug applications (NDAs) for initial approval of drug products in the U.S., and abbreviated new drug applications (ANDAs) for approval of so-called "generic” drugs in the U.S. We assist in determining the status of over-the-counter (OTC) drugs and compliance with applicable monographs, or as competitors to "old" drugs that are currently marketed.

We have assisted clients whose new drug product approval comes with distribution restrictions in the form of a Risk Evaluation and Mitigation Strategy (REMS). In this regard, we have also advised clients regarding the implications of refusal to deal positions that some innovator drug companies have taken for their REMS drug products for requests by generic companies to acquire the REMS drug for bioequivalence testing and ANDA approval. In these instances, we have not only advised the innovator or generic drug manufacturer, but also the specialty pharmacies that distribute and oversee the drug use by the patients.

Our attorneys advise clients seeking NDAs on certain benefits in the form of exclusivities and/or Patent Term Restoration they may receive with the approval of the drug product. These include the requirements for orphan drug designation and exclusivity, NDA market and data exclusivities, and pediatric exclusivities. We also advise clients on the possibilities of priority review vouchers for various rare pediatric disease or tropical diseases that they may be pursuing. For approved products, we advise both foreign and domestic clients on the requirements for drug establishment registration and drug listing whether they may be making for themselves or by contract for others.

We advise clients on compliance issues, including current good manufacturing practice requirements; labeling and advertising issues; conducting product recalls; U.S. FDA inspection practices; providing guidance on compliance programs, policies, and implementation; and defending against government enforcement actions. Members of our FDA practice have assisted clients in defending against competitor challenges in court and other forums. Our team routinely provides advice to drug manufacturers, distributors, reverse distributors, and third-party logistics (3PLs) related to compliance with the Drug Supply Chain Security Act of 2013 requirements. Our FDA litigation attorneys regularly provide counseling on product liability issues for drug manufacturers and defend clients on such issues in court. We have forged relationships with various non-legal FDA consultants who assist clients in preparing premarket new drug applications, INDs, and other regulatory matters in the U.S.