GUIDANCE DOCUMENT
New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers March 2026
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2024-D-4388
- Docket Number:
- FDA-2024-D-4388
- Issued by:
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Guidance Issuing OfficeCenter for Drug Evaluation and Research
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers.” This draft guidance is intended to assist applicants requesting New Clinical Investigation exclusivity (also referred to as 3-year exclusivity) for a new drug application (NDA) or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 FDA intends to update this draft guidance document to include additional Q&As as appropriate.