Brandon von Kriegelstein

Katten Muchin Rosenman LLP

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Latest Posts › Food and Drug Administration (FDA)

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FDA Scrutinizes Clinical Trials Exporting U.S. Genetic Material

On June 18, 2025, the U.S. Food and Drug Administration (“FDA”) announced an immediate review of new clinical trials that export American citizens’ biological materials to countries of concern, such as China, for genetic...more

7/1/2025 / China , Clinical Trials , Data Privacy , Export Controls , Food and Drug Administration (FDA) , Genetic Materials , National Security , Personal Data , Regulatory Requirements , Sensitive Personal Information

FDA Requesting Comments on Proposed Guidance Regarding 510(k) Transfers

On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance...more

6/30/2025 / Comment Period , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , New Guidance , Proposed Rules , Regulatory Oversight , Regulatory Requirements , Supply Chain

FDA Reimagined: Faster, Friendlier, and Focused on Cures

On June 10, 2025, the Commissioner of the FDA, Dr. Martin Makary, and Dr. Vinayak Prasad, the Director of the FDA’s Center for Biologics Evaluation and Research, published an article in JAMA discussing the “Priorities for a...more

6/17/2025 / Artificial Intelligence , Biologics , Drug Pricing , Food and Drug Administration (FDA) , Healthcare Reform , Machine Learning , Medical Devices , Prescription Drugs , Public Health , Regulatory Reform

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