JD Supra2d
Foreign Drug and Medical Device Manufacturers Under a Second Trump Administration: Increased Enforcement Scrutiny?
As discussions intensify about how the second Trump administration will reshape the regulatory landscape for U.S.-based life sciences firms, ...
MassDevice4d
FDA medtech regulators are among latest Trump layoffs
The AP reported that the Trump administration's latest federal cuts have a significant effect on medical device regulation at ...
STAT3d
Health AI: How recent FDA layoffs could shift regulatory burden to health systems
Tech adoption might slow down if the FDA layoffs shift responsibility for medical device and AI safety to hospitals.
BioPharma Dive2d
In FDA job cuts, experts see threat of far-reaching impact
"Any place that gets cut, it's going to have an impact, because there's not any spare personnel at FDA,” said former agency ...
STAT3d
FDA cuts hit AI division, even as Trump invests in the technology
WASHINGTON — The layoffs over the weekend at the Food and Drug Administration appear to ... with their potential to halt or hobble AI regulation, have caused alarm both inside and outside ...
Medical Design and Outsourcing8d
Nasal vaccine devices: Design and regulatory need-to-knows
Nasal vaccine devices have the potential to offer more convenient and more effective protection against a variety of viruses.
medtechdive12d
Former FDA head Gottlieb calls for less regulation of certain AI tools
Gottlieb, who led the FDA from 2017 to 2019, wrote that “recent changes to policies related to the regulation of AI have ...
FDA Layoffs Impact Neuralink Trials and Medical Device Approvals
FDA Layoffs Shake Up Neuralink Trial Review Team. In a surprising move, the U.S. Food and Drug Administration (FDA) has laid off around 20 employees from its Office of Neurologica ...
JD Supra1d
Health Canada Proposes Regulations to Mitigate Drug and Medical Device Shortages
Health Canada recently published draft regulations to address therapeutic product shortages in Canada. The Regulations Amending Certain ...
pna3d
FDA, Japan's PMDA strengthen ties to accelerate regulation processes
The Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) met on Tuesday to optimize the facilitated review pathway (FRP) to expedite access to essential ...