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Title: Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act ; Draft Guidance for Industry; Availability (2019-522) 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