Hosted on MSN1h
Six months “a very limited window” for medical device shortage flagging
Beta CEO Marcel Botha talks about the FDA’s plans for medical shortage notifications and how Trump’s policies may impact US ...
JD Supra2h
FDA's Final Rule for Laboratory Developed Tests
The FDA’s Webinar for Manufacturers and Other Interested Parties - The U.S. Food and Drug Administration (FDA) will host a webinar ...
JD Supra2h
Health Canada proposes to amend the Food and Drug Regulations and Medical Devices Regulations to address shortages
Health Canada published proposed amendments to the Food and Drug Regulations and Medical Devices Regulations to ...
devdiscourse3h
Kennedy Commits to Diverse Clinical Trial Regulations Amid FDA Scrutiny
Robert F. Kennedy Jr. vows to finalize regulations for greater diverse patient involvement in clinical trials during his ...
Truthout2d
Trump Aims to Overhaul the FDA. What Does That Mean for Public Health?
Meanwhile, in an executive order, Trump created his long-discussed “Department of Government Efficiency,” to be led by Elon ...
US FDA drops web pages on improving clinical trial diversity
The U.S. Food and Drug Administration has pulled draft guidance from its website requiring companies to test medicines and ...
FierceBiotech12d
FDA's device chief calls for more authority to address supply chain shortages impacting pediatric, neonatal patients
While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are ...
MassDevice2d
FDA selects a CDRH official as acting commissioner
Dr. Sara Brenner, who has been FDA CDRH's in vitro diagnostics chief medical officer, is serving as acting commissioner of ...
STAT12d
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 ...