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The Most Engaging Decision You’ll Read All Year – Five Stars

FDA Law

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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ACI To Host Multiple Events Featuring HP&M Speakers – Discounts Available to FDA Law Blog Readers

FDA Law

His presentation will focus on “MoCRA is Here – Now What? Charles assists clients across a range of FDA-related regulatory matters by providing timely strategic advice on new drug and biologic development and helping them tackle complex regulatory issues. On March 20-21, Counsel John W.M. The discount code is S10-896-896L24.S.

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Urinary Incontinence Revisited: George Kuchel & Alison Huang

GeriPal

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

IT 120
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Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

GeriPal

Alex 00:59 And I met all three of you and watched you do a presentation about psilocybin research at the Congress International Desens Palliative Miguel. Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? Because we don’t.

Illness 107
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New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product Innovations

FDA Law

If you are developing such products, now may be the time to explore the opportunities presented by the Breakthrough Devices Program. Although not directly relevant, the FDA Innovation Challenge program called “ Devices to Prevent and Treat Opioid Use Disorder ” may provide you with an idea.

Medical 53
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Advance Care Planning Discussion: Susan Hickman, Sean Morrison, Rebecca Sudore, and Bob Arnold

GeriPal

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. Certainly, it was the healthcare providers who were looking for a decision, but that was because a decision needed to be made, and sometimes that’s inescapable. Other fields have had to do that.

Illness 72
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Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

FDA Law

The Attorney General also released DOJ’s Office of Legal Counsel (“OLC”) opinions providing the rationale and support for the NPRM. The Attorney General, after considering HHS’ recommendations, “concludes that there is, at present, substantial evidence that marijuana does not warrant control under schedule I.” 44,597 (May 21, 2024).