Pending EO 12866 Regulatory Review


RIN: 0910-ZD63         Received Date: 08/11/2026 
Title: Frequently Asked Questions--Developing Potential Cellular and Gene Therapy Products; Final 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