CDER Office Medication Error Prevention and Risk Management director Claudia Manzo describes the change in REMS format to SPL.
FDA posts a six-item Form FDA-483 that cites analytical laboratory Valisure over deficient laboratory practices after a 5/26-7/6/22 agency inspection....
Writing in a JAMA Viewpoint, CDER director Peter Marks et al say that continuing to develop variant-specific vaccine boosters is inadequate as a long-...
Spectrum Laboratory Products recalls three lots of epinephrine (L-adrenaline) USP due to product discoloration complaints.
Two AI experts say there should be new baseline performance standards incorporated in algorithms that are submitted to FDA for review, as protection a...
FDA says it is partnering with Health Canada for an eSTAR submission pilot to involve nine participants.
The Association for Accessible Medicines makes several recommendations it says will improve an FDA draft guidance on an evaluation of the sameness of ...
AdvaMed sends FDA five recommendations about the appropriate use of consensus standards.
