FDA publishes a draft guidance on the content of human factor and usability engineering information to be included in medical device marketing submiss...
Two stakeholder associations comment on an FDA draft guidance on general clinical pharmacology considerations for pediatric studies of drugs.
Dewei Medical Equipment recalls its DNA/RNA Preservation Kits because the products were distributed to U.S. customers without FDA authorization, clear...
FDA commissioner Robert Califf says the agency is preparing a manuscript to outline a strategy for getting more diversity into clinical trials.
FDA amends the emergency use authorizations of the updated (bivalent) Moderna and Pfizer-BioNTech Covid-19 vaccines for use in children as young as si...
Federal Register notice: FDA announces that AstraZeneca redeemed a priority review voucher for Imjudo (tremelimumab), which was approved 10/23.
Federal Register notice: FDA makes available a final guidance on pharmacokinetic-based criteria for supporting alternative dosing regimens for program...
FDA asks Oncopeptides to withdraw the accelerated approval of multiple myeloma therapy Pepaxto (melphalan flufenamide) after a confirmatory trial fail...
