Newsletter - November 30, 2023
CAR-T Therapies Cause Cancer? FDA Investigates Multiple Reports of Link
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...Read More
FDA Set to Reclassify Several Wound Dressings to Class III Medical Devices
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...Read More
CAR-T Therapies Cause Cancer? FDA Investigates Multiple Reports of Link
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...Read More
FDA Set to Reclassify Several Wound Dressings to Class III Medical Devices
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...Read More
