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Orthofix petitions FDA requesting that it promptly enact a 4/2013 proposed rule on Use of Certain Symbols in Labeling to facilitat...[ Price : $8.95]
Federal Register Notice: FDA makes draft recommendations available for new permitted daily exposure for two residual solvents.[ Price : $8.95]
Valeant Pharmaceuticals says it recently received subpoenas from both the U.S. Attorneys Office for the District of Massachusetts ...[ Price : $8.95]
FDA grants accelerated approval for a Boehringer Ingelheim NDA for Praxbind (idarucizumab) for use in patients who are taking the ...[ Price : $8.95]
FDA issues a final version of Guidance for Industry #229 Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pat...[ Price : $8.95]
FDA issues AstraZeneca a complete response letter regarding its NDA for the investigational fixed-dose combination of saxagliptin ...[ Price : $8.95]
FDA places on partial clinical hold a Zafgen Phase 3 study of beloranib in Prader-Willi Syndrome, a rare genetic disorder with a h...[ Price : $8.95]
The California Life Sciences Association reports recent improvements in medical device review performance at CDRH in an analysis o...