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
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
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.
California Academy of Family Physicians (CAFP)
MAY 14, 2025
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.
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.
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. The waiting lists can be long depending on available manpower and resources. Thus, surgical robots are the prodigies of surgery.
ABIM
JUNE 12, 2025
The questionnaire gathers information about clinical work and practice patterns, and ABIM uses the information to help update exam blueprints, develop policies for initial certification and MOC, and ensure adequately diverse representation of the profession in research. Learn More Subscribe to the ABIM Blog to stay on top of the latest news.
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