OIRA Conclusion of EO 12866 Regulatory Review
| RIN: 0910-ZA83 View EO 12866 Meetings | Received Date: 11/03/2020 |
| Title: Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act ; Draft Guidance for Industry; Availability (2019-522) | |
| Agency/Subagency: HHS / FDA | Stage: Notice |
| Concluded Action: Consistent without Change | Concluded Date: 11/12/2020 |
| Legal Deadline: None | Economically Significant: No |
| Publication Date: | Unfunded Mandates: No |
| Major: No | Related To Homeland Security: No |
| Regulatory Flexibility Analysis Required: No | Small Entities Affected: No |
| Federalism Implications: No | Affordable Care Act [Pub. L. 111-148 & 111-152]: No |
| International Impacts: No | Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]: No |
| Pandemic Response: No | |
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