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CBER says it expects to publish 35 draft and final guidances this calendar year, including several likely-to-be controversial draf...[ Price : $8.95]
FDA says Novo Nordisk and Lilly should remove statements about the potential for suicidal ideation and behavior from labeling for ...[ Price : $8.95]
FDA warns Indias Chemspec Chemicals about CGMP deviations in its manufacturing of active pharmaceutical ingredients.[ Price : $8.95]
FDA warns Purushothaman Kumaran about failing to follow the investigational plan for a bioequivalence study at a hospital in Pondi...[ Price : $8.95]
FDA issues an untitled letter to BeOne Medicines USA, finding that its direct-to-consumer television advertisement for cancer drug...[ Price : $8.95]
The National Security Commission on Emerging Biotechnology recommends 22 policy actions in five key areas to modernize FDA medical...[ Price : $8.95]
FDA accepts for review a PharmaEssentia supplemental BLA seeking to expand the label of its interferon therapy Besremi to include ...[ Price : $8.95]
Former FDA Oncology Center for Excellence director Richard Pazdur warns that political interference and internal upheaval are erod...