The Association for Accessible Medicines makes several recommendations it says will improve an FDA draft guidance on an evaluation of the sameness of ...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.
BioMarin Pharmaceutical says it is submitting to FDA additional long-term data (three years) as part of the ongoing BLA review for Roctavian (valoctoc...
Zyno Medical agrees to pay $493,000 to resolve allegations that it violated the False Claims Act by causing the submission of claims to Medicare invol...
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; ...
