Abigail Luhn

Abigail Luhn

Faegre Drinker Biddle & Reath LLP

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Latest Posts › Food and Drug Administration (FDA)

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The FDA Is in the Doghouse

An unusual pet food case filed this summer in the District Court of Colorado has a pet food manufacturer as the plaintiff rather than a defendant. Lystn, LLC v. FDA, No. 1:19CV01943 (D. Colo. July 5, 2019)....more

9/9/2019  /  Administrative Procedure Act , Animal Food , Declaratory Relief , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Injunctive Relief , Salmonella , Zero Tolerance Policies

FDA’s Final Guidance on “Least Burdensome” Principles for Medical Devices

The U.S. Food & Drug Administration’s (FDA’s) Least Burdensome Provisions: Concept and Principles: Guidance for Industry and Food and Drug Administration Staff, February 5, 2019, states that “medical device regulation should...more

5/10/2019  /  Final Guidance , Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices , Pharmaceutical Industry
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