Lexology February 5, 2024
As we predicted, the U.S. Food and Drug Administration (FDA) has permanently adopted many of the remote evaluation tools it piloted during the COVID-19 pandemic as the agency seeks to increase its oversight of manufacturers and the global supply chain. FDA continues to expand guidance in this area, including a July 2022 draft guidance titled “Conducting Remote Regulatory Assessments” — revised and expanded in a Q&A-style draft guidance published on January 25, 2024 — and an October 2023 draft guidance on remote interactive requests. Further, FDA recently stated that a forthcoming proposed rule amending 21 C.F.R. Part 1271, applicable to human cells, tissues, and cellular and tissue-based products (HCT/Ps), will establish requirements for the submission of records or other information...
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