Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were ...
Beta CEO Marcel Botha talks about the FDA’s plans for medical shortage notifications and how Trump’s policies may impact US ...
Health Canada published proposed amendments to the Food and Drug Regulations and Medical Devices Regulations to ...
The "FDA Inspections: From Site Preparation to Response" training has been added to ResearchAndMarkets.com's offering. This is a practical, hands-on two-day seminar designed to provide pharmaceutical, ...
Meanwhile, in an executive order, Trump created his long-discussed “Department of Government Efficiency,” to be led by Elon ...
Robert F. Kennedy Jr. vows to finalize regulations for greater diverse patient involvement in clinical trials during his ...
As AI in the medical device space rises, it likely means 2025 will be another challenging year for cyber threats in ...
While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are ...
The U.S. Food and Drug Administration has pulled draft guidance from its website requiring companies to test medicines and ...
How the FDA and CMS worked together on a new approach to paying for digital mental health treatments
By establishing coding and separate payment for certain digital mental health devices, this group from CMS and the FDA hopes ...
Dr. Sara Brenner, who has been FDA CDRH's in vitro diagnostics chief medical officer, is serving as acting commissioner of ...
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