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FDA plans a public workshop on the clinical development of drugs for preventing serious infections caused by Staphylococcus aureus...[ Price : $8.95]
B. Braun Medical gains FDA approval for Nutrilipid 20% (I.V. fat emulsion) for parenteral nutrition therapy in adult and pediatric...[ Price : $8.95]
CDERs Office of Prescription Drug Promotion notifies Concordia that a professional telephone script for its Kapvay omits important...[ Price : $8.95]
FDA issues a draft guidance revising a 2009 predecessor on clinical pharmacology labeling for human drug products.[ Price : $8.95]
Former FDAer Henry Miller says changes should be made to clinical trial design and statistical analyses to better achieve personal...[ Price : $8.95]
CDRH posts a draft guidance on the De Novo Classification Process (Evaluation of Automatic Class 3 Designation).[ Price : $8.95]
AstraZeneca reports that three Phase 3 clinical trials evaluating lesinurad as a combination therapy, met primary endpoints in tre...[ Price : $8.95]
FDA grants fast track designation to Agios Pharmaceuticals for its first-in-class IDH2 mutant inhibitor AG-221 for treating patien...