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Machine Learning Algorithms Pharmaceutical Industry

King & Spalding

FDA Announces Completion of AI-Assisted Scientific Review Pilot and Deployment of Agency-Wide AI-Assisted Review

King & Spalding on

On May 8, 2025, the Food and Drug Administration (FDA) announced the completion of its generative artificial intelligence (AI) pilot program for scientific reviewers. FDA Commissioner Marty Makary was quoted in the...more

Hogan Lovells

FDA advances AI-powered review of medical product applications

Hogan Lovells on

If the initiative proceeds as planned, it will mark a pivotal shift in the regulatory landscape, introducing both efficiencies and novel questions related to the reliability and validity of the AI reviews, as well as...more

McDonnell Boehnen Hulbert & Berghoff LLP

AI News Roundup – OpenAI and FDA discussing AI for drug approval, AI chatbots fuel wave of cheating at U.S. colleges, AI bots...

To help you stay on top of the latest news, our AI practice group has compiled a roundup of the developments we are following....more

Goodwin

FDA to Phase Out Animal Testing for Monoclonal Antibodies and other Drugs

Goodwin on

On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced it will be phasing out the current requirements for animal testing in the development of monoclonal antibody therapies and other drugs, replacing them...more

Hogan Lovells

AI Health Law & Policy: FDA’s rapidly evolving regulatory paradigms

Hogan Lovells on

Artificial intelligence has become one of the most transformative forces in health care, reshaping everything from drug discovery to diagnostics. For pharmaceutical and medical device companies, AI-driven solutions present...more

Troutman Pepper Locke

2024 Mid-Year Review: State AGs Shaping Regulatory Landscapes

Troutman Pepper Locke on

In 2024, the landscape of state attorneys general (AGs) is poised for significant change, with numerous elections and regulatory actions reshaping priorities and enforcement strategies. This dynamic environment reflects the...more

Troutman Pepper Locke

New FDA Guidance on AI and Medical Products

Troutman Pepper Locke on

n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

American Conference Institute (ACI)

[Event] 15th Annual Advanced Forum on Managed Care Disputes and Litigation - May 2nd - 3rd, Chicago, IL

ACI’s Advanced Forum on Managed Care Disputes and Litigation offers an unparalleled learning experience, specifically designed for the MCO legal community. Attend and develop winning legal strategies and business best...more

Epstein Becker & Green

Unpacking Averages: Searching for Bias in Word Embeddings Trained on FDA Regulatory Documents

Epstein Becker & Green on

This post explores how bias can creep into word embeddings like word2vec, and I thought it might make it more fun (for me, at least) if I analyze a model trained on what you, my readers (all three of you), might have written....more

A&O Shearman

EU legislative proposals to impose additional obligations on medical device companies

A&O Shearman on

Connected medical devices are used to assist with diagnosing, monitoring or treating a medical condition and thereby facilitate the remote management of a medical condition by healthcare professionals. Such medical devices...more

Knobbe Martens

AI & the FDA

Knobbe Martens on

The use of artificial intelligence (AI) in healthcare has been growing rapidly in recent years, and AI-enabled medical devices are playing a larger role in patient care. Such devices may use machine learning algorithms to...more

Womble Bond Dickinson

Computer Science Meets Medicine in Drug Discovery

Womble Bond Dickinson on

AI has the potential to revolutionize healthcare worldwide. In drug discovery, AI has already shown success. Sumitomo Dainippon Pharma and the UK-based AI company Exscientia developed DSP-1181 to treat obsessive compulsive...more

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