Pending EO 12866 Regulatory Review

RIN: 0910-ZD49	Received Date: 07/10/2026
Title: Determining Whether to Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; Availability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