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Biogen agrees to pay $900 million in largest FCA Settlement Ever Secured without Government’s Intervention

FDA Law Blog

Department of Health and Human Services (HHS) and the Department of Justice (DOJ) have aggressively pursued antikickback cases in the healthcare industry. This lawsuit was brought to the U.S. district court of Massachusetts by former employee and whistleblower Michael Bawduniak in April 2012 as a qui tam action. See United States ex rel.

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Urinary Incontinence Revisited: George Kuchel & Alison Huang

GeriPal

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. On our last podcast about urinary incontinence the song request was, “Let it go.” I do like that one.

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. We’ll discuss three recent clinical trials involving patients with serious illness, joined by our guests James Downar , Ali John Zarrabi , and Margaret Ross. It’s there.

Illness 107
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Advance Care Planning Discussion: Susan Hickman, Sean Morrison, Rebecca Sudore, and Bob Arnold

GeriPal

All decisions are made in advance, the question that we are debating is how far in advance and what to call it. Completion of advance directives and billing codes for advance care planning as quality metrics. Among other topics. We can work it out! Links to a few couple items mentioned on the podcast: Objectives for Advance Care Planning.

Illness 72
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FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog

It’s important to note here that the warnings and precautions listed in the acetaminophen labeling complied with FDA’s Pregnancy Rule (which applies to all OTC systemic products), stating “if pregnant or breast-feeding ask a health professional before use,” and with the acetaminophen OTC Monograph and the relevant NDAs.

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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.” and lacked accepted safety for use under medical supervision. 21 U.S.C. § 21 U.S.C. § NPRM at 44,619. NPRM at 44,601. Basis at 37; NPRM at 44,610.

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Senator Durbin Has Questions About FDA’s “Operational Capacity” to Oversee DTC Prescription Drug Advertising Amid Workforce Reductions – Don’t We All?

FDA Law Blog

Commissioner Makary has taken a more subdued stance, stating in a podcast with Megyn Kelly that FDA doesnt have any plans to ban direct-to-consumer advertising, but there are some things that we can do to make sure that the information being presented is a complete picture.