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Federal Register Notice: FDAs Blood Products Advisory Committee will meet 1/9/09 to discuss BLAs from CSL Behring and GTC Biother...[ Price : $8.95]
FDA cancels a device registration listing for a companys single-shot handgun after determining that the pistol is not a medical de...[ Price : $8.95]
Two industry executives call on President-elect Obama to name a strong leader to run FDA and to give the new commissioner sufficie...[ Price : $8.95]
AEI scholar John Calfee calls for data exclusivity periods of at least 12 to 14 years for follow-on biologics to encourage needed ...[ Price : $8.95]
FDA asks the Cardiovascular and Renal Drugs Advisory Committee for input into safety and efficacy concerns with Acuspheres Imagify...[ Price : $8.95]
FDA approves GlaxoSmithKlines Boostrix vaccine [tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine, adsorb...[ Price : $8.95]
ImClone Systems submits a BLA for Erbitux (cetuximab) to expand the drugs use to include first-line treatment of patients with adv...[ Price : $8.95]
CDER provides guidance for OTC drug labels to give a reporting address or phone number for serious adverse events.