News & Analysis as of

Risk Management Reporting Requirements Food and Drug Administration (FDA)

Hogan Lovells

FDA warns of “important” clinical trial protocol deviations

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for sponsors, investigators, and...more

McDermott+

FDA Issues Final Guidance on Predetermined Change Control Plans for AI-Enabled Devices

McDermott+ on

On December 3, 2024, the US Food and Drug Administration (FDA) published final guidance titled, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software...more

Mintz - Health Care Viewpoints

Looking Back and Moving Forward: MoCRA Regulatory Developments Ring in the New Year

A year has passed since Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA) and enhanced the Food and Drug Administration’s (FDA) authority to regulate the cosmetics industry. Although MoCRA implementation...more

Gardner Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

Gardner Law on

US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

King & Spalding

FDA FY 2021 Budget Foretells Medical Device Cybersecurity Reform

King & Spalding on

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

Stinson LLP

Missouri Financial Institutions Must Prepare for Impending Marijuana Banking Challenges

Stinson LLP on

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

Bergeson & Campbell, P.C.

TSCA Reform: An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA

The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) makes important changes to the Toxic Substances Control Act (TSCA) that result in fundamental shifts in the requirements and approach under the...more

Pillsbury Winthrop Shaw Pittman LLP

A Lifelong Commitment: FDA Releases Postmarket Guidance on Cybersecurity Risk Management for Medical Device Manufacturers

On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance titled “Postmarket Management of Cybersecurity in Medical Devices,” setting forth proposed recommendations for the medical device industry as...more

Troutman Pepper

FDA's Expanding Views on Cybersecurity and Medical Devices: Draft Guidance on Postmarket Management of Cybersecurity

Troutman Pepper on

Medical device manufacturers need to consider cybersecurity controls in all aspects of the product development process, from conception through commercialization. In response to concerns about increased cybersecurity...more

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