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New Regulations › Risk Management › Food and Drug Administration (FDA)

Hogan Lovells

FDA finalizes cyber device “select updates” guidance, potentially affecting substantial equivalence findings for 510(k)s

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently finalized its March 2024 select updates to its guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (“Premarket...more

Beveridge & Diamond PC

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

Beveridge & Diamond PC on

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

Gardner Law

Staying Prepared Amid FDA Changes

Gardner Law on

Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory enforcement. On the contrary, the...more

Morgan Lewis - Well Done

Navigating FDA from 2024 into 2025 Human Foods Program

Morgan Lewis - Well Done on

FDA Restructures its Food Resources Although there were a number of significant new regulations, the most significant food industry change in 2024 was the overhaul of how FDA structures itself to regulate foods generally....more

Rothwell, Figg, Ernst & Manbeck, P.C.

Regulating AI: An Overview of Federal Efforts

Rothwell, Figg, Ernst & Manbeck, P.C. on

This first part of a two-part series on U.S. regulation of artificial intelligence systems provides an overview and modern context for the existing regulatory, legal and risk management landscape for AI systems in the U.S.,...more

Foley Hoag LLP

New Regulatory Pathway for Cannabidiol Products May be Forthcoming

Foley Hoag LLP on

The Food and Drug Administration (FDA) released a statement yesterday explaining its conclusion that a new regulatory pathway is needed to allow for greater oversight and to better manage risks associated with cannabidiol...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Health Care Compliance Association (HCCA) on

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

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