A CDER podcast gives drug companies steps to follow to be better able to handle recalls quickly and efficiently.
FDA releases the 2019 National Antimicrobial Resistance Monitoring System Integrated Summary showing that salmonella resistance in humans remained ste...
The Justice Department says an American Regent drug production supervisor has been sentenced to jail time and payment of restitution for stealing thou...
A new study about the influence of data disclosures on physician decisions about off-label uses suggests that there is limited awareness of, and expos...
A new Government Accountability Office report recommends that FDA and other HHS agencies develop procedures for reporting and addressing allegations o...
FDA issues Teva Pharmaceuticals and MedinCell a complete response letter on their NDA for TV-46000/mdc-IRM (risperidone extended-release injectable su...
Federal Register notice: FDA announces a 5/18-19 meeting of the Science Advisory Board to the National Center for Toxicological Research (NCTR) Adviso...
Based on adverse events received, FDA sends Warning Letters to 12 companies for selling unapproved over-the-counter products intended to bleach or lig...