Risk Management, Regulatory Reform, Food and Drug Administration (FDA)

FDA Commissioner Makary Promises “Real Time” Release of Complete Response Letters: Can FDA Really Do That?

Ropes & Gray LLP on 7/17/2025

On July 10, 2025, in the name of embracing “radical transparency,” the U.S. Food and Drug Administration (“FDA”) announced that it was publishing more than 200 complete response letters (“CRLs”) issued in response to drug and...more

FDA Proposes New Tool for Post-Market Scientific Assessment of Food Ingredients

Morgan Lewis - Well Done on 6/30/2025

On June 18, 2025, FDA announced for public comment a Post-market Assessment Prioritization Tool (Prioritization Tool) as an enhanced systematic process for post-market scientific assessment of chemicals in food, including...more

FDA to Overhaul Post-Market Chemical Review Program for Food Chemicals

Beveridge & Diamond PC on 6/18/2025

Key Takeaways - What Happened: The U.S. Food and Drug Administration (FDA) announced plans to update its food safety post-market chemical review program over the next few months to increase transparency and accelerate its...more

Executive Orders on Domestic Production of Critical Medicines and Biological Research Security

Baker Donelson on 5/9/2025

What Happened? The President signed two companion Executive Orders (EO) on May 5, 2025 that collectively signal a significant federal pivot toward (i) accelerating the domestic manufacture of pharmaceuticals deemed "critical"...more

FDA’s evolving regulatory framework for AI use in drug & device clinical trials and research

Hogan Lovells on 1/14/2025

U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product...more

FDA FY 2021 Budget Foretells Medical Device Cybersecurity Reform

King & Spalding on 2/25/2020

Increased premarket submission and post-market reporting requirements potentially on the horizon for high-tech devices. The Food and Drug Administration’s (“FDA’s”) budget proposal for FY2021 telegraphs FDA’s plan to seek new...more

Missouri Financial Institutions Must Prepare for Impending Marijuana Banking Challenges

Stinson LLP on 1/15/2020

In November 2018, Missouri voters passed Amendment 2, setting in motion state regulated medical marijuana. Over the last month, the Missouri Department of Health & Senior Services (DHSS) began approving license applications...more

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