Joseph Mallon

Joseph Mallon

Knobbe Martens

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Edwards v. Meril at the Supreme Court: Testing the Scope of Hatch-Waxman’s Safe Harbor

On October 11, 2024, Edwards filed a petition for a writ of certiorari with the U.S. Supreme Court. The question presented, as framed by Edwards, is: “Whether, under Hatch-Waxman’s safe harbor, an infringing act is “solely...more

12/20/2024  /  Amicus Briefs , Clinical Trials , En Banc Review , Food and Drug Administration (FDA) , Hatch-Waxman , Infringement , Medical Devices , Petition for Writ of Certiorari , Safe Harbors , SCOTUS

FDA Provides Perspective on Goals and Challenges for Regulation of Artificial Intelligence in Medical Devices, Drug Design, and...

A recent article authored by Haider J. Warraich, MD; Troy Tazbaz; and Robert M. Califf, MD in the Journal of the American Medical Association, reviews the history of artificial intelligence (AI) regulation by the U.S. Food...more

11/27/2024  /  21st Century Cures Act , Artificial Intelligence , Clinical Trials , Drug Design , Food and Drug Administration (FDA) , Medical Devices , Prescription Drugs , Public Health , Regulatory Agenda , Software
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