FDA commissioner Stephen Hahn and deputy commissioner for medical and scientific affairs Anand Shah describe agency steps to promote advanced manufact...
GlaxoSmithKline (XXX DELETE XXX)and Sanofi separately disclose that they are being investigated by the U.S. Justice Department over alleged False Clai...
Four former FDA commissioners urge U.S. regulators, researchers and Covid-19-recovered patients to join in an effort to collect blood plasma and begin...
Federal Register notice: FDA announces the rates for biosimilar user fees for fiscal year 2021.
FDA releases its latest batch of Warning Letters that includes Acrx Specialty Pharmacy, Fishman Chemical and MMSTabs.com.
Federal Register notice: FDA makes available a final guidance entitled Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric ...
Federal Register notice: FDA makes available guidance documents related to Covid19 public health emergency.
Federal Register notice: FDA seeks comments on a report entitled Independent Evaluation of the GDUFA Resource Capacity Planning Adjustment Methodology...