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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)

Imposes New (State-Only) Medi-Cal Premiums for Undocumented Adults – Implements $100 monthly premiums for undocumented adults aged 19 and older, effective January 1, 2027. Proposed Changes to Prescription Drug Coverage Prescription Drug Utilization Management- Implements utilization management and prior authorization for prescription drugs.

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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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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.

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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. We, and many stakeholders, agree that RWD and RWE can play an invaluable role. Congress has recognized the challenges with FDA’s acceptance of RWD and RWE.

Medical 111
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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

By end of Q2 FY 2023, FDA will enhance its internal systems to support review of DHT-related submissions including capturing key information about clinical trials utilizing DHTs to support tracking the number and rate of change of DHT related submissions.