Day: November 30, 2023

This week FDA made an explosive announcement that there are reports of new cancers in patients treated with several approved CAR-T therapies. Although the FDA added the disclaimer that the benefit of these treatments still outweighs the risk of the same, the news is sure to rattle patients who received these treatments over the last … Read more

A new proposed rule intends to reclassify several wound dressings from 510k to Class III PMA medical devices based on the use of certain types of antimicrobials in these products. FDA will also create new product codes for several wound dressings that are currently designated as pre-amendment unclassified medical devices. Many of these wound dressings … Read more