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Pharmacists in Florida (and Elsewhere): Waive Prescribing Red Flags at Your Peril

FDA Law Blog

The government’s expert testified that any red flag associated with a controlled substance prescription must be resolved and that resolution documented before dispensing. By Larry K. Coconut Grove Pharmacy; Decision and Order, 89 Fed. 50,372 , 50,377 (June 13, 2024). make a record of its resolution, assuming it is resolvable.”

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Transgender Health, Aging, and Advocacy: A Podcast with Noelle Marie Javier and Jace Flatt

GeriPal

Just today (June 17th) as we record this podcast: Ezra Klein released a wonderful interview with Sarah McBride , the first openly transgender member of congress A judge ruled that cuts to NIH grants focused on minority groups, including transgender people, were illegal and ordered the government to restore funding. Can you tell me about that?

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The MAHA Assessment’s Implications: Drugs (Part One)

FDA Law Blog

Ordinarily, a public health initiative of such magnitude would have been governed by a transparent multi-step process featuring public meetings and drawing on external scientific expertise. In other words, as you read this, the Assessments findings and recommendations are getting baked into federal government policy, for better or worse.

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How State and Local Agencies on Aging Help Older Adults: Susan DeMarois, Greg Olsen, and Lindsey Yourman

GeriPal

Summary Transcript Summary You may have heard of Area Agencies on Aging, but do you really know what they do or how they do it? What about State Departments of Aging or state master plans for aging? Do you know how these agencies fit in with programs like Meals-on-Wheels or other nutritional support programs? Susan: It is my anthem.

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Guiding an Improved Dementia Experience (GUIDE) Model: A Podcast with Malaz Boustani and Diane Ty

GeriPal

Summary Transcript Summary We’ve talked a lot about comprehensive dementia care on the GeriPal podcast but while the evidence is clear that these programs work, the uptake has been limited largely because there hasn’t been a strong financial case for it. It requires a fight. It’s been going on for many decades now. Malaz: I love it.

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FDA Approves First State Drug Importation Program Under 20-Year-Old Statute, But High Hurdles Remain

FDA Law Blog

The government would require at least another 30 days to examine the shipment at the U.S. Kirschenbaum — The law permitting the importation of cheaper prescription drugs from Canada—Section 804 of the Federal Food, Drug, and Cosmetic Act (FDC Act)—has been on the books for decades. See 21 C.F.R. 251.5; § 251.6(c). See 21 C.F.R.

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Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities

FDA Law Blog

Currently, individual Medicare Part D plan sponsors negotiate rebates but the government is explicitly prohibited from interfering in those negotiations. The attraction of the repeal is that Part D negotiations can potentially save the federal government “hundreds of billions of dollars,” as explained in the Plan.