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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. million federal funds) in 2025-26 to support additional ACEs provider training. million total funds ($1.46

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

FDA Law Blog

When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and planned initiatives for the coming years, we were both excited by many of the announcements, while recognizing the real success will come from how the Agency implements them. The endpoints must be novel (i.e.

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When Worlds Collide: The Theory of Real-World Evidence Meets Reality

FDA Law Blog

Further, FDA has stated that enabling advanced data analytics, including RWD, is one of the objectives incorporated in the FDA’s Information Technology Strategy for FY 2024-2027. Rather than looking at how RWD/RWE provide meaningful information on safety and effectiveness, reviewers often focus on perceived gaps.

Medical 111
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FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

FDA Law Blog

This FR Notice and draft strategy document are part of FDA’s commitment under the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures for Fiscal Years 2023-2027 (PDUFA VII), wherein FDA committed to advance the use and implementation of innovative manufacturing.

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Wearables, Sensors, and Apps Part 1 – Updates on FDA’s PDUFA VII Goals for the Use of Digital Health Technologies in Drug and Biological Product Development

FDA Law Blog

This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.