Since 1984, FDA has had authority to recognize three years of regulatory exclusivity for certain qualifying new drug applications that conduct new clinical investigations essential for its approval. Despite no shortage of controversy, nuance, challenges, and litigation in the intervening decades on its application of these provisions, FDA’s public-facing interpretation of these provisions was limited to slim regulation, citizen petition responses, and court filings. After promising its publication for some time, FDA has issued the draft guidance New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers .
