FDA accepts for review an Otsuka Pharmaceutical and H. Lundbeck supplemental NDA for Rexulti (brexpiprazole) in combination with sertraline for treati...
FDA warns Cartersville, GA-based Sani-Care Salon Products about CGMP violations in its work as a contract manufacturer of finished drugs.
FDA warns the Carmel, IN-based Indiana Lions Eye Bank about deviations from the regulations for human cells, tissues, and cellular and tissue-based pr...
CDER Office of New Drugs Special Program Staff associate director Yoni Tyberg discusses the New Drug Regulatory Program modernization and its successe...
Advanced Medical Technology Association says there are inconsistencies and ongoing concerns with FDAs guidance on remanufacturing/servicing medical de...
Regeneron calls on FDA to develop two guidances to further the use of precision medicine in non-oncology diseases.
Glenmark Pharmaceuticals recalls (Class 1) 114 batches of potassium chloride extended-release capsules, USP (750 mg), due to dissolution concerns.
A House subcommittee report claims that FDA cut corners in its usually rigorous processes and bowed to Biden Administration political pressure in appr...
