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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. GLP-1 Drugs for Weight Loss : Ends coverage for GLP-1 medications used for weight loss starting January 1, 2026.

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

The Medical Futurist

Assisting surgeries, disinfecting rooms, dispensing medication, keeping company: believe it or not these are the tasks medical robots will soon undertake in hospitals, pharmacies, or your nearest doctor’s office. Instead of a human, however, they used a mannequin designed for medical training.

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

FDA Law Blog

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). RWE is “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.” By Jeffrey N.

Medical 111
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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. The phase out period applies to LDTs currently on the market in reliance on FDA’s enforcement discretion policy (“affected laboratories”). Part 803 and notices of correction and removal under 21 C.F.R.

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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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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.