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...
FDA warns Sun Pharmaceuticals about CGMP violations and other issues in its production of finished drugs in Gujarat, India.
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-...
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.
BioMarin Pharmaceutical says it is submitting to FDA additional long-term data (three years) as part of the ongoing BLA review for Roctavian (valoctoc...
