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AAFP Represents Members During 2025 Legislative Session

Alabama Academy of Family Physicians

The updated tax credit seeks to incentivize physicians to serve in underserved rural communities, addressing longstanding healthcare disparities and bolstering access to medical care for Alabama’s rural residents. What Happened: The Senate Committee on Finance and Taxation Education did not meet to discuss the bill.

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Green Practice News: May 2025

My Green Doctor

In This Issue : Why Renewable Energy Belongs in Every Clinic Medical Waste: One Model for Improvement OnTrack with your Sustainability Goals? Our Consulting Services offer customized strategies for group practices, health systems, and medical societies ready to accelerate their impact and lead the way in climate-smart care.

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Look What the Cat Dragged In: FDA’s Draft Guidance on Urinary Tract Health Claims for Cat Food

FDA Law Blog

Acknowledging concerns about urolithiasis, pet food manufacturers use a range of formulation strategies to make UTH cat food, which have included limiting the magnesium content or formulating it to produce slightly acidic urine. Upper bound of 95% CI ≤ 2.5 CaOx: Mean RSS ≤ 6.0; Upper bound of 95% CI ≤ 2.5 CaOx: Mean RSS ≤ 6.0;

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Jennifer Newberger Returns to HPM as a Director After Stints with Apple, Abbott Laboratories, and Cognito Therapeutics

FDA Law Blog

(HPM) proudly announces the return of Jennifer Newberger as a Director, further boosting its already robust medical device practice. Jennifer’s combination of experiences as in-house counsel for both large and start-up companies as well as outside counsel provides clients invaluable expertise and problem-solving skills.

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Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

FDA Law Blog

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ). The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies.

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Could the Road to an AKS Violation Be Paved with Good Intentions? Pfizer Asks SCOTUS

FDA Law Blog

Pfizer manufactures tafamidis (sold under brand names Vyndaqel and Vyndamax), a breakthrough treatment for a rare, progressive heart condition called transthyretin amyloid cardiomyopathy (ATTR-CM). The Court found that there is at best little utility in interpreting the AKS by reference to the BIS. Background.

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Discounts Available! Submit a Small Business Certification Request Today for a Reduced Medical Device User Fee

FDA Law Blog

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — In our last blog post , we advised medical device companies to consider applying to FDA’s Small Business Program to help with the noticeably higher user fees for FY2023. In this blog post, we provide a primer on user fees and the Small Business Program.

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