Pending EO 12866 Regulatory Review
| RIN: 0910-ZC67 | Received Date: 11/26/2025 |
| Title: New and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act; Draft Guidance for Industry; Availability | |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]: Yes |
| Pandemic Response: No | Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]: No |
An official website of the United States government



