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Federal Register notice: FDA makes available a guidance on Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-B...[ Price : $8.95]
United Therapeutics again petitions FDA to request that the agency not approve any generic form of its Tyvaso that fails to meet c...[ Price : $8.95]
FDA says Genentech is recalling three lots of Activase 100 mg vials co-packaged with Hospira sterile water in vials that may be cr...[ Price : $8.95]
FDA concerns about PD-1/PD-L1 inhibitors spread to clinical trials for multiple myeloma, lymphoma and leukemia conducted by AstraZ...[ Price : $8.95]
FDA deputy commissioner Anna Abram says the agency is soliciting public input as it reviews all of its regulations looking for way...[ Price : $8.95]
CDERs V. Ashutosh Rao describes the work Office of Biotechnology Products laboratory researchers are doing to improve the quality,...[ Price : $8.95]
FDAers discuss issues facing the agency in trying to continue its momentum in approving orphan drug designations.[ Price : $8.95]
FDAs Kansas City District Office warns Mylan EpiPen product supplier Meridian Medical Technologies about CGMP and QS violations in...