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A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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Big Win for HP&M Client: Court of Appeals Tells FDA to Regulate Barium Sulfate As a Device

FDA Law Blog

Genus Medical Technologies secured an important victory in the D.C. In Genus Medical Technologies v. FDA , the Court of Appeals ruled that FDA cannot regulate a medical product – in this case, the radiographic contrast agent barium sulfate – as a drug when the product meets the definition of a device.

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Episode 309 – Antiracism in Medicine Series – Episode 23 – Anti-Blackness, Anti-Fatness, and Food Shaming

The Clinical Problem Solvers

Harrison Time Stamps 00:00 Opening 00:45 Introductions 03:07 Guest Introduction 1 04:46 Guest Introduction 2 08:15 On the Intersection of Black, Fat, and Trans Communities and the Medical-Industrial Complex 13:35 History and the Racial Underpinnings of Food Shaming in the U.S. Episode Takeaways Origin Stories – For Dr. Psyche A.

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Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

GeriPal

AFP 2019 Gabapentin for chronic neuropathic pain in adults. It’s not a controlled substance medication. Eric: So I heard gabapentin is the 10th most commonly prescribed medication in the US. In psychiatry, a lot of the anti-epileptic medications, we call them mood stabilizers and are used in bipolar disorder.

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Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

GeriPal

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. So medication adjustments.

Illness 107
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Arsenicum album for Kerala school students: a bogus prophylaxis

Tiny Physician

Indian Medical Association (IMA) Kerala wing criticized the minister at that time as the medicine lacked scientific evidence (2). Even a basic understanding of chemistry, biology, and physics is enough to debunk the concepts in this pseudoscience. Budget 2019: In fillip to traditional medicine, AYUSH ministry gets Rs 1,939.76

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Knock Knock. Who’s There? (or Quién es? or Qui est-ce? or Wer ist es?) Surprise, it’s FDA!

FDA Law Blog

Claud On May 6, 2025, FDA announced that it planned to conduct more surprise inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for U.S. Walsh & Esther Petrikovsky & John W.M. is safe, legitimate, and honestly made. In a recent Executive Order (E.O.)