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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 May revision proposes eliminating and suspending much of this funding.

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

FDA Law Blog

FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices. RWE is “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.”

Medical 111
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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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From Surgeries To Keeping Company: The Place Of Robots In Healthcare

The Medical Futurist

Robotic nurses dressing mannequins and bed-bathing patients Delicate movement, like gently handling an elderly patient is traditionally the most challenging task to robots, who are much faster developing in intellectual tasks than matching humans in fine-motor skills. By 2027, global surgical robotics sales are expected to reach $14.8

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Proposed LDT Rule Raises Many Questions but Provides Few Answers

FDA Law Blog

The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. What, if any, unintended consequences may result from the proposed phaseout policy to certain patient populations (for example, Medicare beneficiaries, rural populations, etc.) 150,000).”

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No Sleep ‘Til District Court: Jazz Sues FDA Over Sodium Oxybate Clinical Superiority Determination

FDA Law Blog

This time, rather than use codes and patent certifications, the fight is over orphan drug exclusivity (“ODE”), with Jazz challenging FDA’s clinical superiority decision concerning sodium oxybate in the treatment of narcolepsy. 360cc(c), the statute does not permit FDA to promulgate regulations to use clinical superiority to break ODE. .

Clinic 52
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RWE There Yet? FDA’s New Pilot Program Seeks to Help Usher in a New Era for Real World Evidence

FDA Law Blog

These data are routinely collected from a variety of sources, such as electronic health records, providing information on health and healthcare in actual patients, rather than in the controlled environment of a clinical trial. There will be two submission deadlines per year on March 31 and September 30, through March 31, 2027.