Pending EO 12866 Regulatory Review


RIN: 0910-ZC70         Received Date: 12/17/2025 
Title: M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality; International Council for Harmonisation; Draft Guidance for Industry; Availability 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]: No
Pandemic Response: No Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]: No