Business · 04/03/2026Updated: 10/16/2026 · 1 min read
FDA Announces Draft Guidance on New Clinical Investigation Exclusivity for Drug Products
Summary
The FDA is releasing a draft guidance to help applicants understand the criteria for 3-year exclusivity for new drug applications and provide recommendations on the format of requests for exclusivity.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →