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Ranbaxy hires former GOP presidential hopeful Rudy Giuliani to review FDA compliance issues from recent Warning Letters and an Imp...[ Price : $8.95]
CDRH corrects an erroneous enforcement statistic presented by director Dan Schultz at a RAPS session in Boston 9/15.[ Price : $8.95]
FDA issues an ICH guidance to help sponsors select appropriate doses for rodent carcinogenicity studies.[ Price : $8.95]
FDA says Gilead Sciences must conduct another clinical trial on its investigation cystic fibrosis drug aztreonam lysine.[ Price : $8.95]
Daiichi Sankyo files an sNDA for its Azor as initial hypertension therapy in patients likely to need multiple drugs to meet blood ...[ Price : $8.95]
CDRH director Daniel Schultz tells a Senate committee there are significant regulatory differences and requirements between DTC ad...[ Price : $8.95]
FDA approves W.L. Gores Gore Viabahn endoprosthesis for use in patients with symptomatic peripheral arterial disease in iliac arte...[ Price : $8.95]
Federal Register Final rule: FDA approves an Animal Health Pharmaceuticals supplemental NADA for revised labeling for an oral susp...