Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to ...
Kelly, who made several key hires at the CDRH and helped negotiate the last user fee agreement, announced his departure in a ...
GlobalData on MSN12h
Nearly a third of FDA medical device adverse event reports filed lateA new study found that 9.1% of medical device AEs were reported to the FDA 180 days later than required over a three-year ...
Duke patients in a new study prefer patient portal messages written using artificial intelligence — until they learn AI wrote ...
Three U.S. senators are calling on Robert Kennedy Jr. to disclose what he and President Trump discussed with drugmakers ...
The employees returned Monday. An industry source with knowledge of the matter said “most, if not all of the CDRH people are being asked back.” One of the CDRH employees said people on their team who ...
The CDRH had a total of 2,230 employees as of 2023. Annual reports describing the number of employees in 2024 and previous years were recently removed from the FDA’s website.
Medical Device Network on MSN7d
FDA issues early alert for Baxter’s Spectrum infusion pumpThe US Food and Drug Administration (FDA) has issued an early alert over a ‘potentially high-risk’ issue with certain Baxter ...
Orthopedic surgery is a marvelous field because we can make meaningful improvements in the comfort and function of patients ...
HuffPost on MSN16d
Oops! Trump Accidentally Fired FDA Medical Device ReviewersThe Food and Drug Administration is scrambling to bring back hundreds of critical workers laid off en masse by DOGE.
With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices.
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback