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.
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
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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.
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
AUGUST 23, 2023
DHTs have been used in clinical trials for decades in the context of measurements made when participants visit clinical trial sites. DHTs have been used in clinical trials for decades in the context of measurements made when participants visit clinical trial sites.
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. What, if any, unintended consequences may result from the proposed phaseout policy to certain patient populations (for example, Medicare beneficiaries, rural populations, etc.)
FDA Law Blog
JUNE 14, 2023
The striking phrase “valley of death,” is generally understood to refer to the tendency for innovative technologies to fail to reach market, whether due to reimbursement and/or physician or patient preference. Also, it is unclear which office within CDRH appoints the TAP Advisor, e.g., center-level, OPEQ-level, or division-level.
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