In March 2026, the Food and Drug Administration (FDA) issued draft guidance for the industry, New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers, providing additional clarity on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. Three-year exclusivity, established by the Hatch-Waxman Amendments, may apply to certain new drug applications (NDAs) and NDA supplements that rely on new clinical investigations essential to approval and conducted or sponsored by the applicant. During the exclusivity period, FDA may not approve certain 505(b)(2) applications or abbreviated new drug applications (ANDAs) for the exclusivity-protected conditions of approval.