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Federal Register Notice: FDAs Gastroenterology and Urology Devices Panel will meet 12/2-3 to discuss Oceana Therapeutics Solesta a...[ Price : $8.95]
Federal Register Notice: FDAs Science Advisory Board to the National Center for Toxicological Research will meet 10/19-20 to hear ...[ Price : $8.95]
Roche says FDA should consider two criteria in determining whether to permit two or more new molecular entities in combination dru...[ Price : $8.95]
FDA accepts for review an AstraZeneca NDA for its investigational drug vandetanib, indicated for treating patients with advanced m...[ Price : $8.95]
CBER says labeling for GlaxoSmithKlines Rotarix has been updated to include postmarketing trial information suggesting an increase...[ Price : $8.95]
A reading of FDA safety review memos for Avandia illustrates the difficult internal debate the agency constantly faces in its post...[ Price : $8.95]
FDA approves a Mylan Pharmaceuticals ANDA for a generic version of Astellas' Prograf capsules used in preventing organ transplant ...[ Price : $8.95]
Parexel Consulting says companies developing follow-on biologics are interested in how FDA will treat monoclonal antibodies.