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New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
Read on FederalRegister.gov · Official PDF · Docket on Regulations.gov · Add to calendar (.ics)
Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers." This draft guidance is intended to assist applicants requesting New Clinical Investigation exclusivity (also referred to as 3-year exclusivity) for a new drug application (NDA) or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 FDA intends to update this draft guidance document to include additional Q&As as appropriate.
- Document type
- Notice
- Federal Register document number
- 2026-04291
- Published
- Mar 4, 2026
- Action
- Notice of availability.
- Docket
- FDA-2024-D-4388
- Comments posted on Regulations.gov (at last check)
- 0
- DATES section (from the document)
- Submit either electronic or written comments on the draft guidance by May 4, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Submit electronic or written comments on the proposed collection of information in the draft guidance by May 4, 2026.
- Topics (auto-tagged)
- Clinical
Source: Federal Register API, document 2026-04291. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.