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AAFP Represents Members During 2025 Legislative Session

Alabama Academy of Family Physicians

By engaging with lawmakers and key stakeholders, the Academy worked to ensure that the voices of family physicians were heard in discussions that have the potential to impact healthcare delivery and access for communities across the state. What Happened: This legislation has been enacted into law.

Insurance 130
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FDA Draft Guidance: Everything You May Want to Know about OMUFA Fees

FDA Law

The draft guidance provides information regarding various aspects of the OMUFA program under sections 744L and 744M of the FDC Act, as added by the CARES Act. The facility fee applies to a single manufacturing facility. Size, revenue, and number of finished drug products manufactured at a facility do not affect the OMUFA facility fee.

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Urinary Incontinence Revisited: George Kuchel & Alison Huang

GeriPal

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Incontinence and avoiding issues can present in an older individual, in some cases, just like they do a younger person. That can be incredibly informative. Everybody ages.

IT 120
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Key Bills in the 2025 Legislative Session AAFP is Watching Closely

Alabama Academy of Family Physicians

The new program has additional eligibility requirements, including that the physician must have practiced outside of a rural community for at least three years before returning to a rural area. Any contractual clause that limits or penalizes providers for sharing this information would be unenforceable.

Insurance 130
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A Reversal on Sequencing? Proposed Legislation Would Allow Patenting of Naturally Occurring Genes

FDA Law

Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. The concerns raised by PERA are not limited to these industries, however. HPM is currently representing AMP in unrelated litigation.)

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

GeriPal

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? So classically with preparation, in individual settings or even in group settings, you have one or two people supporting people through psychoeducation, what to expect, life review.

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

FDA Law

This 2022 draft guidance proposed that certain non-addictive medical products for pain or addiction treatment could be eligible for breakthrough designation, aligning with the Agency’s obligations under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act. Emphasis added.)

Medical 53