Pending EO 12866 Regulatory Review

RIN: 0910-ZD97	Received Date: 10/21/2026
Title: Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management; Draft Guidance for Industry
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