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The Association for Accessible Medicines makes several recommendations it says will improve an FDA draft guidance on an evaluation of the sameness of ...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.
CDERs first cycle approval rate for NDAs/BLAs approved in 2022 fell from 86% in 2021 to 76% (28 of the 37 novel approvals) in 2022, while other import...
CDER dismisses any concern over the 26% drop in NDAs/BLAs approved in 2022, which saw approvals decline from 50 in 2021 to 37 last year.
