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The U.S. Food and Drug Administration (FDA) had only exercised its authority to ban medical devices twice by the time it finalized its ban on electrical stimulation devices (ESDs) for…
April 4, 2022 With great sadness, we announce that our firm’s co-founder, leader, colleague and friend, Jim Phelps passed away on April 2, 2022, at the age of 83. Jim…
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Every year, the Food and Drug Law Institute (FDLI) publishes a compendium of the Top Food and Drug Cases from the previous year, as well as Cases to Watch, in…
Every year, the Food and Drug Law Institute (FDLI) publishes a compendium of the Top Food and Drug Cases from the previous year, as well as Cases to Watch, in…
Citing agency experience and expertise, courts have long afforded federal agencies discretion in administering their respective statutes. But, in Genus Med. Techs., LLC v. United States FDA, 2021 U.S. App….
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…with Best Lawyers for the 2021 “Best Law Firms” rankings. We’re truly honored! But the honors don’t stop there. HP&M was also once again ranked as a “Tier 1” law…
On November 15, 2021, the U.S. Department of Health and Human Services (“HHS”) and the Food and DrugAdministration (“FDA”) issued several policy changes governing the regulation of Laboratory Developed Tests(“LDTs”)….