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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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Lots of FDA Guidance, But Few Drug Manufacturing “Remote Interactive Evaluations” (We Would Call Them “Virtual Inspections”)

FDA Law Blog

A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections.

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It’s the Law Now –Cybersecurity Information in Premarket Submissions

FDA Law Blog

Shapiro — Does your firm manufacture a “cyber device”? The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.”

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9 Technologies That Will Shape The Future Of Dentistry

The Medical Futurist

Just like in the case of other medical specialties , disruptive innovations will have a huge impact on how dentistry will be practiced and how patients will take care of themselves in the future. With AI tools having access to such information, they can instantly offer the best treatment options and probabilities of success.

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Is my Software a Medical Device? Use the Digital Health Policy Navigator

FDA Law Blog

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — With the explosion of health‑related software, many software developers are generating products with functionality that is subject to regulation by the Food and Drug Administration (FDA).

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Can a Device Be Found Not Substantially Equivalent Because of Cybersecurity Risks? A Review of FDA’s Draft Guidance on Cybersecurity in Medical Devices

FDA Law Blog

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance. are cybersecure.

Medical 105
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FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

FDA Law Blog

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). products intended for medical purposes).

Medical 98