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
MARCH 6, 2024
His presentation will focus on “MoCRA is Here – Now What? Featuring speakers from the USPTO, FTC, FDA, distinguished members of the Judiciary, and in-house and outside counsel, HP&M Director Kurt Karst will be a presenter at the 20th Annual Paragraph IV Disputes Conference , April 25 – 26 in New York, NY.
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GeriPal
JUNE 20, 2024
Incontinence and avoiding issues can present in an older individual, in some cases, just like they do a younger person. But then there is incontinence, which is the same term, same word, but actually presents as a geriatric syndrome. Most of the trials that have been conducted are conducted by the manufacturers of those medications.
GeriPal
MAY 8, 2025
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.
FDA Law Blog
OCTOBER 17, 2023
If you are developing such products, now may be the time to explore the opportunities presented by the Breakthrough Devices Program. Additionally, the 2022 draft guidance suggested the addition of a new section to the 2018 guidance on reducing disparities in health and healthcare.
GeriPal
MARCH 24, 2022
But I do think POLST, which I conceptualize as an advance care planning tool, really sits in between those worlds of decisions that are relevant for the present versus the few future. First of all, this does feel primarily like a manufactured controversy. And it I think really highlights how that’s a very blurry line.
FDA Law Blog
MAY 21, 2024
The Attorney General, after considering HHS’ recommendations, “concludes that there is, at present, substantial evidence that marijuana does not warrant control under schedule I.” The Attorney General also released DOJ’s Office of Legal Counsel (“OLC”) opinions providing the rationale and support for the NPRM. NPRM at 44,619.
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