Pending EO 12866 Regulatory Review

RIN: 0910-ZC68	Received Date: 12/01/2025
Title: New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers; Draft Guidance for Industry; Availability
Agency/Subagency: HHS / FDA	Stage: Notice
Legal Deadline: None	Economically Significant: No
International Impacts: No	Affordable Care Act [Pub. L. 111-148 & 111-152]: No
Pandemic Response: No	Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]: No