FDA issues Allergan a refuse-to-file letter on a supplemental NDA for Vraylar (cariprazine) for treating negative symptoms associated with schizophren...
FDA approves an Abbott Diabetes Care PMA for the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose monitoring system that ...
FDA releases a FDA-483 issued to a Dr. Reddys drug manufacturing facility in the UK.
CDER publishes a MAPP on procedures and responsibilities for Office of New Drug completion and processing of annual status reports on sponsor postmark...
FDA warns Chinas Shandong Vianor Biotech about CGMP violations in its production of finished pharmaceuticals.
CDER medical reviewers say a PTC Therapeutics contested NDA for Translarna does not contain persuasive evidence for the drugs effectiveness in treatin...
FDA worries about medical product shortages as the damage from a hurricane that devastated Puerto Rico is assessed as worse than first predicted.
CDRH director Jeffrey Shuren and two colleagues say the Center has been using patient-focused data to help in the review of some medical device applic...