FDA acting commissioner Janet Woodcock calls for greater independence from drug companies in the nations clinical trial processes and procedures.
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Federal Register notice: FDA releases a draft guidance on adjusting for covariates in drug/biologic clinical trials.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...
Federal Register notice: FDA announces a 6/10 Vaccines and Related Biological Products Advisory Committee meeting to discuss Covid19 pediatric vaccine...
Federal Register notice: FDA announces a 7/15 Cardiovascular and Renal Drugs Advisory Committee meeting to review FibroGen anemia drug for use in kidn...