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

FDA Law Blog

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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Urinary Incontinence Revisited: George Kuchel & Alison Huang

GeriPal

George 03:01 So I would say that as many clinical issues in older adults, we need to think about them in two ways. Incontinence and avoiding issues can present in an older individual, in some cases, just like they do a younger person. And we can talk about that later in terms of potential clinical implications that may have code.

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

GeriPal

We’ll discuss three recent clinical trials involving patients with serious illness, joined by our guests James Downar , Ali John Zarrabi , and Margaret Ross. Alex 00:33 Our next guest is Margaret Ross, who’s a clinical psychologist and researcher at St. Dr. James, welcome to the GeriPal Podcast. James 00:32 Good afternoon.

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

FDA Law Blog

If you are developing such products, now may be the time to explore the opportunities presented by the Breakthrough Devices Program. In October 2022, FDA released the draft guidance entitled “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare,” as previously discussed in our blog.

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

GeriPal

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.

Illness 72
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Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

FDA Law Blog

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. Basis at 24.

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Arsenicum album for Kerala school students: a bogus prophylaxis

Tiny Physician

Treating with sugar pills : why homeopathic principles are unscientific Arsenicum album lacks evidence from randomized controlled trials Image taken from zeenew.india.com If you take the pain to search “Arsenicum album” in PubMed, you will find hardly 3 clinical trials conducted on this medicine. References 1.