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.

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FDA Law Blog

JUNE 15, 2022

Kirschenbaum — In 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule to significantly decrease the rate the government will reimburse 340B hospitals in 2018 for outpatient prescription drugs from average sales price (“ASP”) plus 6% to ASP minus 22.5%. 52494 (Nov. citing §1395 l (t)(14)(A)(iii)(II)).

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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. Attorney General Jeff Sessions rescinded prior DOJ guidance on marijuana enforcement, including the Cole Memo, in January 2018. Merrick Garland, Testimony Before the Senate Subcommittee on Appropriations, Apr. 21 U.S.C. §

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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.

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GeriPal

MARCH 2, 2023

JAMA Surgery 2018 Gabapentin and mood stabilizers in the Nursing Home Setting: Antiepileptic prescribing to persons living with dementia residing in nursing homes: A tale of two indications. By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. Tasce: I do.

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FDA Law Blog

OCTOBER 17, 2023

FDA previously released the final guidance document in December 2018 outlining the program’s principles, features, designation criteria, and other considerations. Additionally, the 2022 draft guidance suggested the addition of a new section to the 2018 guidance on reducing disparities in health and healthcare. Emphasis added.)

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GeriPal

MARCH 24, 2022

2018 Systematic Review of Systematic Reviews on ACP. 2018 Systematic Review of Systematic Reviews on ACP. We’re going to be talking about advance care planning, serious illness communication, what’s what, what’s up with both, is either of them good. Among other topics. We can work it out! AlexSmithMD.

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