2025 Manufacturing Provider Relationship 
FDA Law Blog
MAY 7, 2025
On April 14, 2025, the Seventh Circuit overturned the criminal conviction of Mark Sorensen, the owner of a durable medical equipment (DME) distributor, who had been found guilty of violating the AKS. Sorenson follows the Fifth Circuits decision last year in United States v. Marchetti, 96 F.4th Marchetti, 96 F.4th Polin , 194 F.3d
Physician's Practice
JUNE 9, 2025
of Roetzel & Andress June 9, 2025 By Austin Littrell Fact checked by Keith A. Financial Relationships with Pharmaceutical Companies (00:20:10)** Legal and ethical concerns for physicians with financial ties to GLP-1 drug manufacturers, including anti-kickback laws. Austin Littrell June 2nd 2025 Podcast Tom Price, M.D.,
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FDA Law Blog
SEPTEMBER 20, 2021
Torrente, explained in a previous post , in-person meetings create important opportunities for building rapport, and lead to more robust dialogue and collegial relationships between the Agency and sponsors. Livornese and Josephine M. based upon the anticipated clinical benefit of earlier patient access to the product.”.
FDA Law Blog
NOVEMBER 8, 2022
Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF). To paraphrase from our blog post , EUAs are triggered by an EUA declaration; FDA will publish advanced notice for an EUA declaration and provide a 180 day notice before the implementation of the transition plan.
FDA Law Blog
MAY 26, 2025
Specifically, these are procedures and drugs used in providing what HHS had, until recently, referred to as gender-affirming care. The political battle went into gear on January 28, 2025, with an Executive Order titled Protecting Children from Chemical and Surgical Mutilation. 116(e) (emphasis added).
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