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MN Legislative Session 2025: Updates on Hearings and Bills

Minnesota Academy of Family Physicians

Meanwhile, Democrat David Gottfried ‘s win in the Roseville special election has tied the Minnesota House (67 Republicans, 67 Democrats), shifting the balance of power and influencing which bills move forward in coming weeks. Committee Hearing Updates Last week saw several key legislative hearings.

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Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft

FDA Law

In fact, eSTAR does not allow a PCCP to be included in a Special 510(k); attempting to do so results in the message if you are establishing a PCCP this should not be done in a Special 510(k). Manufacturers should develop the Modification Protocol consistent with their quality system and should follow their risk management processes.

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Endocrinology, Diabetes and Metabolism Board Meeting Summary | Spring 2025

ABIM

See the discussion on the Special Consideration IMG (International Medical Graduates) Pilot Pathway below.) Special Consideration IMG Pilot Pathway* In August 2024 , the ABIM Council proposed a pilot model for exceptionally qualified IMGs pursuing accredited subspecialty fellowship in the U.S.

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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. CMS will require participating manufacturers to submit and attest to this ownership information in the Health Plan Management System (HPMS).

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Infectious Disease Board Meeting Summary | Spring 2025

ABIM

Members pointed to challenges in access to care and medication in states that rely heavily on federal funding, health program funding cuts that affect HIV prevention and treatment, and managing fear and uncertainty in patients, particularly those in rural and underserved communities.