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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...[ Price : $8.95]
Federal Register notice: FDA announces a 10/30 public workshop entitled CDER Rare Diseases Public Workshop: Strategies, Tools, and...[ Price : $8.95]
FDA commissioner Scott Gottlieb says the agency plans to revamp its early pre-clinical involvement with medical product developers...[ Price : $8.95]
FDA clears an eNeura 510(k) for its Spring TMS, indicated for the acute and prophylactic treatment of migraine headache.