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...
FDA sends AbbVie a second complete response letter on its NDA for ABBV-951 (for carbidopa/foslevodopa) for treating motor fluctuations in adults with ...
Federal Register notice: FDA makes available a final guidance entitled Laboratory Developed Tests (LDTs): Small Entity Compliance Guide.
