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FDA posts a six-item Form FDA-483 that cites analytical laboratory Valisure over deficient laboratory practices after a 5/26-7/6/2...[ Price : $8.95]
Writing in a JAMA Viewpoint, CDER director Peter Marks et al say that continuing to develop variant-specific vaccine boosters is i...[ Price : $8.95]
Spectrum Laboratory Products recalls three lots of epinephrine (L-adrenaline) USP due to product discoloration complaints.[ Price : $8.95]
Two AI experts say there should be new baseline performance standards incorporated in algorithms that are submitted to FDA for rev...[ Price : $8.95]
FDA says it is partnering with Health Canada for an eSTAR submission pilot to involve nine participants.[ Price : $8.95]
The Association for Accessible Medicines makes several recommendations it says will improve an FDA draft guidance on an evaluation...[ Price : $8.95]
AdvaMed sends FDA five recommendations about the appropriate use of consensus standards.[ Price : $8.95]
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...