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Hogan Lovells | USA | 13 Aug 2021

FDA seeks comments on how to transition approved drug products to device status under Genus

On August 9, the U.S. Food and Drug Administration (FDA) published a notice announcing its implementation of the U.S. Court of Appeals for the D.C…
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Davis Wright Tremaine LLP | USA | 6 Aug 2021

Stay ADvised: What's New This Week, August 2

A recently filed class action lawsuit in the Southern District of New York alleges that popular yogurt maker Chobani misled consumers with the "Fair…
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Hogan Lovells | USA | 21 May 2021

Federal court limits FDA discretion in “drug” vs. “device” classification

The U.S. Court of Appeals for the D.C. Circuit recently decided in Genus Medical Technologies LLC v. U.S. Food and Drug Administration that, when…
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Ropes & Gray LLP | USA | 4 May 2021

The Supreme Court’s Decision in AMG Capital Management v. FTC - What Does It Mean for FDA Enforcement?

On April 22, 2021, the Supreme Court unanimously held in AMG Capital Management v. FTC that the FTC’s authority under Section 13(b) of the FTC Act…
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Hogan Lovells | USA | 27 Apr 2021

Biden signs bill limiting new drug exclusivity awards to innovations in active moiety

On April 23, U.S. President Biden signed into law two bills meant to lower prescription drug prices by limiting new drug exclusivity awards and…
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Reed Smith LLP | USA | 20 Apr 2021

Goodbye PACS, Hello MIMPS

In a final rule published April 19 in the Federal Register, the Food & Drug Administration (FDA) amended various medical device regulations so that…
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Hogan Lovells | USA | 15 Apr 2021

U.S. Congress passes the FASTER Act to require sesame allergen labeling

On 14 April 2021, the U.S. Congress passed the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2021 (S. 578), which now heads…
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Hogan Lovells | USA | 15 Apr 2021

FDA issues guidance on conducting remote interactive evaluations during the COVID-19 pandemic

On April 14, the U.S. Food and Drug Administration (FDA) released the immediately-in-effect guidance “Remote Interactive Evaluations of Drug…
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Hogan Lovells | USA | 7 Apr 2021

FDA extends enforcement discretion for UFI food facility registration requirement to December 2022

The U.S. Food and Drug Administration (FDA) recently issued updated guidance that extends agency enforcement discretion over compliance with the…
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Keller and Heckman LLP | USA | 31 Mar 2021

Congressmembers Introduce The Baby Food Safety Act

On March 25, Congressmembers introduced The Baby Food Safety Act of 2021 to amend the Federal Food, Drug, and Cosmetic Act (FDCA) to limit the…
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