Pending EO 12866 Regulatory Review

RIN: 0910-ZC76	Received Date: 02/11/2026
Title: E2D(R1) Postapproval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports; International Council for Harmonisation; 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