Joseph Mallon on Food and Drug Administration (FDA)

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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

Novartis Loses Bid for Preliminary Injunction Against MSN Pharmaceuticals

Judge Andrews of the District of Delaware recently denied Novartis’s request for a preliminary injunction against MSN Pharmaceuticals. Novartis Pharm. Corp. v. MSN Pharm. Inc., Civil Action No. 20-md-2930-RGA, Dkt. No. 1456...more

9/6/2024 / Abbreviated New Drug Application (ANDA) , Food and Drug Administration (FDA) , Generic Drugs , Pharmaceutical Industry , Pharmaceutical Patents , Preliminary Injunctions

USPTO Issues Training Materials to Examiners for Searching FDA and NIH Resources

On March 20, 2024, The USPTO issued an alert, notifying practitioners that the USPTO had developed training materials for patent examiners regarding searching for prior art in FDA and NIH databases. ...more

3/25/2024 / Biotechnology , Food and Drug Administration (FDA) , Healthcare , Intellectual Property Protection , National Institute of Health (NIH) , Over The Counter Drugs (OTC) , Patent Examinations , Pharmaceutical Industry , Prescription Drugs , Prior Art , Training Requirements , USPTO

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Joseph Mallon