FDA Law Blog
JANUARY 15, 2024
FDA , Petitioners, a liquid nicotine manufacturer, sued FDA arguing that the Agency was arbitrary and capricious in rejecting the Petitioner’s Premarket Tobacco Application (“PMTA”) in violation of the Administrative Procedure Act (“APA”). FDA also directed manufacturers to produce detailed marketing plans.
FDA Law Blog
JUNE 15, 2022
billion annually, and continued the same reimbursement cuts for 2019. In 2019, we blogged that the District Court found for the plaintiffs, holding that CMS did not have the statutory authority to make such a change without first conducting a hospital acquisition cost survey data. CMS estimated a savings of $1.6 See 42 U.S.C.
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FDA Law Blog
MAY 2, 2022
They are the most stringently regulated substances of abuse and it is unlawful to manufacture and distribute them. 15 and 16, 2019). 21 U.S.C. § It is important to understand the lead up to Garland’s stance. Jefferson B. Sessions, Memorandum for All United States Attorneys, Jan. Confirmation Hearing on the Nomination of Hon.
The Clinical Problem Solvers
NOVEMBER 6, 2023
Harrison, a community organizer and trans theorist, and Dr. Psyche A. As an editor, movement media and narrative strategist, and storyteller, Harrison uses their extensive history as a community organizer—which began in 2014 during their first year at Morehouse College—to frame their political thought and cultural criticism.
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. Because we don’t.
Common Sense Family Doctor
FEBRUARY 15, 2025
On Sensible Medicine, Dr. Edward Livingston pointed out that the manufacturer, AbbVie, spent $580 million on DTCA for this drug in 2023, or $290 for each of the 2 million potential patients in the United States. The annual price of risankizumab is $288,000, so this is still a huge bargain for the company given the potential returns.
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. Eric: Although pregabalin, right, more misuse of pregabalin out in the community.
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