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. Becerra, No. 20-1114, 596 U. S. _ (2022).

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Hospital Government Provider IT 52

FDA Law Blog

MAY 2, 2022

They are the most stringently regulated substances of abuse and it is unlawful to manufacture and distribute them. In response to states authorizing and legalizing marijuana while it remained a schedule I substance federally, Deputy Attorney General James Cole provided guidance in a memorandum to U.S. Jefferson B.

Manufacturing 52

Manufacturing Medical IT Community 52

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 Additionally, the 2022 draft guidance suggested the addition of a new section to the 2018 guidance on reducing disparities in health and healthcare.

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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. Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? J Am Geriatr Soc.

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Patient-Centered IT Healthcare Medical 96

GeriPal

MARCH 24, 2022

2018 Systematic Review of Systematic Reviews on ACP. And I would say too, as a primary care provider, it really doesn’t take that long to ask people about a surrogate decision maker. Susan: I will share in Indiana, we actually had that as our legal model, that there was a decision making by committee up until 2018.

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Illness IT Healthcare Patient-Centered 73