Pending EO 12866 Regulatory Review


RIN: 0910-ZC67         Received Date: 11/26/2025 
Title: New and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act; Draft Guidance for Industry; Availability 
Agency/Subagency: HHS / FDA   Stage: Notice 
Legal Deadline: None  Economically Significant: No 
International Impacts: Yes Affordable Care Act [Pub. L. 111-148 & 111-152]: Yes
Pandemic Response: No Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]: No