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.
Four major stakeholders give numerous suggestions for significantly changing or improving an FDA draft guidance that revises the agencys approach to d...
An FDA online post explains the benefits of CDER scientists work in proteomics-based biomarker discovery.
