Issue Date: March 3, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): Electronic Submissions, Drug Competition Action Plan, Generic Drugs
Status: Draft
New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers.” This draft guidance is intended to assist applicants requesting New Clinical Investigation exclusivity (also referred to as 3-year exclusivity) for a new drug application (NDA) or NDA supplement. The guidance discusses the statutory and regulatory criteria for eligibility for 3-year exclusivity and provides recommendations on the content and format of requests for 3-year exclusivity in the form of questions and answers (Q&As). FDA intends to update this draft guidance document to include additional Q&As as appropriate.
Download the Guidance Document
