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...
Federal Register notice: FDA sends to OMB an information collection extension entitled Reporting Associated with Designated New Animal Drugs for Minor...
Federal Register notice: FDA sends to OMB an information collection extension entitled Cellular and Tissue-Based Product Deviations in Manufacturing; ...
FDA extends by three months a Krystal Biotech BLA for B-Vec (beremagene geperpavec) after it submitted manufacturing data pursuant to an agency inform...
FDA accepts for priority review an Otsuka Pharmaceutical and H. Lundbeck supplemental NDA for brexpiprazole for use in treating agitation associated w...
Federal Register notice: FDA announces a 2/15 advisory committee meeting to discuss an Emergent BioSolutions supplemental NDA for Narcan (naloxone HCl...
FDA clears a CardiacSense 510(k) for its CSF-3 Watch for monitoring vital signs, such as electrocardiogram, beat-by-beat heart rate, and oxygen satura...
