Q&A: FDA Seeks to Clarify '3-Year Exclusivity' with New Guidance
March 13, 2026Lobbying & Public Policy, Policy & Regulation, Food and Drug Administration (FDA), Life Sciences
In March 2026, the Food and Drug Administration (FDA) issued draft guidance for the industry, New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers, providing additional clarity on eligibility for and requests for 3-year exclusivity under the Federal Food, Drug and Cosmetic Act for qualifying drug products.
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