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Regulatory Oversight Food and Drug Administration (FDA) Corporate Counsel

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

From Algorithms to Approvals: Navigating AI in Drug and Biological Product Regulation

On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more

K&L Gates LLP

FDA Weighs in on Microplastics and Nanoplastics in Food

K&L Gates LLP on

In a development that is expected to complicate many litigation challenges alleging that the presence of low levels of microplastics in food is inherently unsafe, officials from the US Food and Drug Administration (FDA or...more

Hogan Lovells

Five highlights from FDA’s new AI device regulation Action Plan

Hogan Lovells on

On January 12, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence released its new five-part “Artificial Intelligence/Machine Learning (AI/ML)-Based...more

McDermott Will & Emery

[Event] Life Sciences Bootcamp for In-House Counsel - May 14th, Lincolnshire, IL

McDermott Will & Emery on

McDermott’s cross-functional team of life sciences professionals present the inaugural Chicago-Area Life Sciences Bootcamp focusing on issues and trends important to life sciences companies....more

McDermott Will & Emery

[Event] 2019 Life Sciences Bootcamp for In-House Counsel - March 20th, Cambridge, MA

McDermott Will & Emery on

McDermott’s cross-functional team of life sciences professionals present the second annual Life Sciences Bootcamp focusing on issues and trends important to life sciences companies. This half-day program is designed for...more

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