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Medical Devices Federal Food Drug and Cosmetic Act (FFDCA) Generic Drugs

Nutter McClennen & Fish LLP

Product Liability 2018 Year in Review

Massachusetts state and federal courts issued a number of important product liability decisions in 2018. The Product Liability practice group at Nutter recently reviewed these cases. Highlighted below are some of the key...more

Hogan Lovells

There'll Be Some Changes Made: President Signs Prescription Drug and Biologic User Fee Reauthorization Act

Hogan Lovells on

On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more

Polsinelli

New Judicial Interpretations on Scope of Hatch-Waxman Safe Harbor

Polsinelli on

The Federal Circuit recently provided additional clarity about the scope of the Hatch-Waxman safe harbor. In Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., the appellate court sharpened the line between...more

K&L Gates LLP

Global Food, Drugs, Medical Devices and Cosmetics Newsletter

K&L Gates LLP on

Welcome - We are pleased to provide you with the Spring edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. As stated in our inaugural issue, this newsletter provides updates on important...more

Morrison & Foerster LLP

Stengel Tangles MDA Preemption: Ninth Circuit Decision Creates Split on Buckman Preemption of Post-Market Reporting Requirements

Last week the Ninth Circuit created a new state-law cause of action against medical device manufacturers: “failure to warn the FDA.” The en banc opinion in Stengel v. Medtronic Inc., __ F.3d __, 2013 WL 106144, 13 C.D.O.S....more

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