Former FDA head Scott Gottlieb appears on CNBC to throw his support behind commissioner-nominee Heidi Overton on the eve of her Senate confirmation he...
FDA warns Phoenix, AZ-based Specialty Health Products about multiple violations in its marketing of unapproved colonic irrigation systems.
CBER issues a Standard Operating Policy and Procedure on scheduling and conducting regulatory meetings on drugs and biologics.
A federal court has entered a consent decree of permanent injunction against Gold Star Distribution, Inc., prohibiting the Minnesota warehouse operato...
FDA says a meta-analysis performed by CDER scientists suggests that pharmacokinetic similarity studies can often yield sufficient information on biosi...
FDA releases the Form FDA-483 with three observations from its inspection at the Columbus, OH-based STAQ Pharma Ohio outsourcing facility.
An FDA advisory committee votes Wednesday to recommend approval of Grail's Galleri multi-cancer early detection blood test, voting unanimously, 10-0, ...
