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California Academy of Family Physicians (CAFP)
MAY 14, 2025
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.
FDA Law Blog
MAY 13, 2024
FDA has even gone so far as to maintain that the “real-life clinical performance of a medical product might be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users.”
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FDA Law Blog
OCTOBER 6, 2023
The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. direct-to-consumer tests, tests for use in a public health emergency).
The Medical Futurist
MAY 18, 2025
By 2027, global surgical robotics sales are expected to reach $14.8 Clinical use is already accepted, new FDA approvals and new trials are underway targeting new niches, like pediatric surgeries. These new ‘colleagues’ will definitely make a difference in every field of medicine.
FDA Law Blog
SEPTEMBER 20, 2021
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.
FDA Law Blog
JULY 24, 2023
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. .
FDA Law Blog
OCTOBER 24, 2022
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.
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