STAT2 天
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.
MassDevice3 天
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 ...
JD Supra18 小时
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 ...
BioPharma Dive1 天
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 ...
Medical Design and Outsourcing7 天
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.
JD Supra20 小时
FDA Layoffs, RFK Jr. at HHS, and What This Means for FDA-Regulated Companies
In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many ...
pna2 天
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 ...
medtechdive11 天
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 ...
OnePlus seeks FDA approval for Sleep Apnea Detection on its watch and takes on Apple in the ...
OnePlus is hoping the OnePlus Watch 3 could get FDA approval for its new sleep apnea detection feature, bringing it one step ...
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 ...