Pending EO 12866 Regulatory Review


RIN: 0910-ZC92         Received Date: 04/28/2026 
Title: Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; 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