Federal Register notice: FDA posts a final guidance on an extended enforcement policy regarding use of national health related item code and national ...
Federal Register notice: FDA makes available a final guidance on demonstrating bioequivalence for soluble powder drug products.
Medical Action Industries recalls its Medical Convenience Kits that include the BD/Carefusion Chloraprep 3mL applicator, which was earlier recalled du...
Federal Register notice: FDA releases a draft guidance on adjusting for covariates in drug/biologic clinical trials.
FDA issues a final guidance on regulatory, quality, nonclinical, and clinical considerations for bispecific antibody development programs.
CDER director Patrizia Cavazzoni says the Center will apply an intense focus to encourage the pharmaceutical industry to achieve quality management ma...
FDA Review posts the Federal Register notices for the week ending 2/21/2021.
Federal Register notice: FDA makes available a final guidance on premarket submissions for peripheral vascular atherectomy devices.