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Governor’s 2025-26 May Revision Proposes Major Cuts to Healthcare and Undermines Medi-Cal Expansion Commitments

California Academy of Family Physicians (CAFP)

However, for individuals who do not qualify for federal Medicaid funding—such as most undocumented immigrants—the federal government does not provide matching funds, even when those individuals meet income eligibility requirements. The asset limit for a household would be $2,000 for an individual and $3,000 per couple.

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2025 Physician Wellness Retreats | Physician “Burnout” Retreats

Pamela Wible MD

2026 Physician Vision Quest Retreat Dec 3–7, 2025 ~ 1:1 or small group retreat Craving clarity before the new year? Group retreats host 4 to 7 physicians, combining facilitated individual coaching and inspiring group activities. Tax-deductible. CME included. By invitation only. Tax-deductible. 30 hours category 2 CME. Can’t travel?

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AstraZeneca’s Challenge to Price Negotiation Fails in Federal District Court

FDA Law

AstraZeneca also claimed that CMS’s revised guidance on the Negotiation Program for Price Applicability Year 2026 (“Guidance”) interpreted the IRA in two very faulty ways, which violated the Administrative Procedure Act (APA) and harmed and will continue to harm the company. Opinion at 17. see also 42 U.S.C. 1320f-1(e)(1)(A).

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A Temporary Extension for the Rare Pediatric Disease Priority Review Voucher with a Longer-Term Extension in Sight?

FDA Law

Designed to incentivize the development of drugs for pediatric rare diseases where such development may not otherwise have occurred, vouchers may be granted for drugs for serious or life-threatening rare diseases where the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years.

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FDA Issues Long-Awaited QMSR Final Rule

FDA Law

One of the major changes is the extension of the transition period from one to two years, with FDA now planning to enforce the QMSR requirements upon the effective date of the final rule on February 2, 2026. The final rule emphasizes risk management activities and risk-based decision making. FDA further retained some definitions in the QSMR.

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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

Post-market surveillance plans and procedures (PMS) are a requirement under ISO 13485 which will be adopted into FDAs Quality Management System Regulation in 2026. The final guidance clarifies that only an unresolvable failure should preclude implementation; if the failure is resolvable the modification may be implemented after retesting.

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The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law

Notable Dates and Timelines – Program opens, beginning of FY 2023; Expediting reviews fully implemented, by FY 2024; Webpage with detailed criteria for acceptance and participation, October 1, 2022; Interim assessment, end of FY 2025; Public workshop, end of Q2 FY 2026. Notable Dates and Timelines – Applications open, Q4 of FY 2023.