FDA Law Blog
NOVEMBER 1, 2023
Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.
FDA Law Blog
APRIL 19, 2021
The Court decision limiting FDA’s discretion provides regulatory certainty for device manufacturers, as the claimed discretion, if recognized by the Court, would have meant that any medical device potentially could be classified and regulated as a drug. District Court, which sided with Genus in December 2019.
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The Clinical Problem Solvers
NOVEMBER 6, 2023
Between the years 2019 and 2021, Harrison served as Associate Editor—and later as Managing Editor—of Wear Your Voice Magazine. Physical Fitness.” Harrison currently serves as Editor-at-Large at Scalawag Magazine, is a co-host of the podcast “Unsolicited: Fatties Talk Back,” and one third of the video podcast “In The Middle.”
GeriPal
MAY 8, 2025
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.
GeriPal
MARCH 2, 2023
AFP 2019 Gabapentin for chronic neuropathic pain in adults. And for that reason, there was actually an enormous lawsuit, and the manufacturer was fined, now I think 20 years ago, in the millions and millions of dollars for off-label prescribing. Cochrane Database of Systematic Reviews Review.
Tiny Physician
OCTOBER 17, 2021
Even a basic understanding of chemistry, biology, and physics is enough to debunk the concepts in this pseudoscience. It is worth noting that Covaxin, our indigenously developed vaccine manufactured by Bharat Biotech, is on the verge of getting approval in the pediatric age group as well (6). Arsenic Toxicity 8.
FDA Law Blog
MAY 8, 2025
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. is safe, legitimate, and honestly made.
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