January 7, 2025Lobbying & Public Policy, Policy & Regulation, Pharmaceuticals, Medical Devices, Health Care, Policy, Food and Drug Administration (FDA), AI/ML Devices
On January 6 and 7, 2025, the FDA announced, by our count, 31 draft or final guidances, on a wide range of topics. Historically, an incoming administration will impose a temporary freeze on the issuance of guidances and rules, and might ultimately have different policy priorities and goals than the previous administration. Thus, the release of these numerous new guidances reflects topics that the FDA likely views as particularly important to address.
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