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10 Oct 2023, 8:46 pm by Hyman Phelps McNamara
(“HP&M”), the largest FDA-dedicated law firm, is pleased to announce that Julie Beitz, M.D. has joined the firm as a Principal Drug Regulatory Expert. [read post]
29 Sep 2023, 4:30 am
Blackman, No. 3:21-CV-01744 (M.D. [read post]
27 Sep 2023, 5:42 am by Ben Vernia
According to DOJ’s press release: Gregory Stynowick, M.D. and his pain management practice, Pain Management Medical Center LLC, of Florissant, Missouri, and Chad Shelton, M.D., Michael Boedefeld, M.D., and their pain management practice, Pro Pain LLC, of St. [read post]
22 Sep 2023, 10:00 am by Kyle Krull
Although approved by the FDA, the drug has been found to come with major risks of brain swelling and bleeding, according to Amit Sazchdev, M.D., who is the principal investigator for the Lecanemab clinical trial program at Michigan State University and the medical director for neurology and ophthalmology at Michigan State University. [read post]
11 Sep 2023, 10:07 pm by Kurt R. Karst
In a statement released at the time, CDRH Director Jeffrey Shuren, M.D., J.D., stated, “We appreciate the IOM’s report on the 510(k) program. . . . [read post]