Federal Register notice: FDA makes available a guidance on Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P...
United Therapeutics again petitions FDA to request that the agency not approve any generic form of its Tyvaso that fails to meet criteria specified by...
FDA says Genentech is recalling three lots of Activase 100 mg vials co-packaged with Hospira sterile water in vials that may be cracked or chipped and...
FDA concerns about PD-1/PD-L1 inhibitors spread to clinical trials for multiple myeloma, lymphoma and leukemia conducted by AstraZeneca and Celgene, w...
FDA deputy commissioner Anna Abram says the agency is soliciting public input as it reviews all of its regulations looking for ways to revise, update,...
CDERs V. Ashutosh Rao describes the work Office of Biotechnology Products laboratory researchers are doing to improve the quality, safety, and efficac...
FDAers discuss issues facing the agency in trying to continue its momentum in approving orphan drug designations.
FDAs Kansas City District Office warns Mylan EpiPen product supplier Meridian Medical Technologies about CGMP and QS violations in its manufacturing p...