News

American Hospital Association6h

FDA announces labeling changes to opioid pain medications

The Food and Drug Administration July 31 announced that it is requiring safety label changes to all opioid pain medications ...
The American Journal of Managed Care1d

Linvoseltamab Added as Preferred Agent in Newest MM Practice Guidelines

On July 2, linvoseltamab-gcpt (Lynozyfic; Regeneron) received an accelerated approval from the FDA in relapsed/refractory ...

Senate confirms CDC director as top FDA official resigns under political pressure

In a 51–47 vote along party lines, the Senate confirmed Monarez as the director of the Centers for Disease Control and ...
MedPage Today2d

Want to Judge Data on FDA-Cleared AI Systems for Alzheimer's? Good Luck With That

Among 24 such systems (called devices in FDA parlance) authorized since 2015, FDA summaries for 14 lacked data on the ...
Healio3d

White paper urges FDA to act against companies producing counterfeit GLP-1s

Speakers at a congressional briefing on July 22 called on the FDA to take action against the marketing and distribution of ...

100 days into the job, FDA head talks to CNN about agency goals— and Coke’s switch to sugar

Commissioner Marty Makary says the FDA will plow ahead with big plans on ultra process foods, dietary guidelines and ...
JD Supra7mon

FDA Finalizes Guidance on Predetermined Change Control Plans for AI ...

On December 4, 2024, the U.S. Food and Drug Administration (“FDA”) released its final guidance for industry on predetermined change control plans (“PCCPs”) for devices that utilize ...