FDA Guidance for Industry: Processes and Practices Applicable to Bioresearch Monitoring Inspections
Title:
FDA Guidance for Industry: Processes and Practices
Applicable to Bioresearch Monitoring Inspections
Origin/Publisher:
FDA
Content:
FDA is issuing this guidance to comply with section 3612(b)(2) of the Food and Drug Omnibus Reform Act of 2022 (FDORA), enacted as part of the Consolidated Appropriations Act, 2023.2
FDORA directs FDA to issue guidance describing the processes and practices applicable to inspections of sites and facilities described in section 704(a)(5)(C)(i) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act), to the extent not specified in existing publicly available FDA guides and manuals for such inspections