[ Price : $8.95]
Federal Register Final rule: FDA approves an Animal Health Pharmaceuticals supplemental NADA for revised labeling for an oral susp...[ Price : $8.95]
Federal Register Direct final rule: FDA confirms the effective date for a Federal Register final rule removing the requirement for...[ Price : $8.95]
CDER associate director for policy Jane Axelrad tells an industry conference that about one in eight approval actions taken since ...[ Price : $8.95]
House Government Reform and Oversight committee chair Henry Waxman seeks answers from FDA after an internal e-mail suggests that p...[ 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]
CDRH corrects an erroneous enforcement statistic presented by director Dan Schultz at a RAPS session in Boston 9/15.