New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers

5th March 2026

Summary:
This guidance provides questions and answers on the FDA’s approach to new clinical investigation exclusivity, a regulatory protection established under the Hatch-Waxman Act. A three-year exclusivity period may be granted when a drug application or supplement contains reports of new clinical investigations in humans, other than bioavailability studies, that were conducted or sponsored by the applicant and were essential to approval.

The guidance explains which types of applications may qualify, including certain new drug applications (NDAs), 505(b)(2) applications, and supplements to approved NDAs. During the exclusivity period, the FDA may receive and review abbreviated or follow-on applications, but it cannot approve applications that rely on the protected clinical investigations for the approved conditions of use until the exclusivity expires.

The document also clarifies key terms such as “new clinical investigation” and “essential to approval”, and provides examples of situations that may qualify for exclusivity, such as approval of new indications, dosing regimens or patient populations for an already approved drug product.

Link:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/new-clinical-investigation-exclusivity-3-year-exclusivity-drug-products-questions-and-answers

Back to Recent News