Formal Dispute Resolution and the Food and Drug Administration

Marlan Golden


Although appeals of federal administrative agency action receive considerable attention, appeals within administrative agencies are seldom discussed. This Article focuses on FDA’s internal processes for appeals of drug and biologic application decisions, as well as appeals of medical device application determinations. The piece examines FDA’s formal dispute resolution process, emphasizing its pragmatic dimensions, and assesses FDA’s procedural regime and its conceptual core in light of past agency practice and current experience. The role of FDA’s formal dispute resolution process is positioned within the larger regulatory and legal framework of America’s human drug and medical device approval systems.