Pending EO 12866 Regulatory Review


RIN: 0910-ZD69         Received Date: 09/11/2026 
Title: Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; 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