FDA posts an update on its ongoing pilot to develop a medical device software precertification program that notes FDA is leaning toward a question-bas...
Becton Dickinson CareFusion 303 recalls its Alaris System Infusion Pumps due to damaged inter-unit interface connectors, loose or missing battery scre...
Federal Register notice: FDA corrects a 9/2 Federal Register notice that announced the availability of drug post-marketing pediatric-focused safety re...
FDA releases a final guidance on Assessing Covid-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biolo...
FDA issues a temporary guidance entitled Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency to he...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Dyax Corp.s Takhzyro, indicated for prophylaxis...
FDA says it will soon issue a guidance for sponsors to request an Emergency Use Authorization for their vaccines, including recommendations on the dat...
FDA issues Pharmacy Plus (dba Vital Care Compounder) a Warning Letter for offering unapproved drug products for prophylaxis and treatment of, and reco...