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 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.”
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The Medical Futurist
MAY 18, 2025
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
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. This means patients will no longer be automatically grandfathered in for medications that are not on—or are removed from—the Medi-Cal Rx Contract Drug List (CDL).
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.
ABIM
JUNE 12, 2025
Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. For example, in specialties like cardiovascular disease and medical oncology with prevalent geriatric patient populations, concepts like frailty and falls may not be covered in assessment materials.
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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