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Blood Panel to Meet

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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...

Handgun is Not a Medical Device: FDA

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FDA cancels a device registration listing for a companys single-shot handgun after determining that the pistol is not a medical de...

Obama Urged to Appoint Strong Leader to FDA

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Two industry executives call on President-elect Obama to name a strong leader to run FDA and to give the new commissioner sufficie...

Sensible Data Exclusivity Needed for Follow-ons: Calfee

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AEI scholar John Calfee calls for data exclusivity periods of at least 12 to 14 years for follow-on biologics to encourage needed ...

FDA Questions Imagify Safety, Efficacy

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FDA asks the Cardiovascular and Renal Drugs Advisory Committee for input into safety and efficacy concerns with Acuspheres Imagify...

FDA OKs Glaxo Boostrix Vaccine in Adults

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FDA approves GlaxoSmithKlines Boostrix vaccine [tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine, adsorb...

Erbitux BLA Submitted for Lung Cancer

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ImClone Systems submits a BLA for Erbitux (cetuximab) to expand the drugs use to include first-line treatment of patients with adv...

OTC Adverse Event Label Requirements Clarified

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CDER provides guidance for OTC drug labels to give a reporting address or phone number for serious adverse events.

Risk Panel to Discuss Info Available to Patients

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Federal Register Notice: FDAs Risk Communication Advisory Committee will meet 2/6 to discuss information available on medication g...

Sandoz Downplays Big Heart Drug Recall

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Consulting editor John Scharmann reviews Sandoz Inc.s efforts to downplay manufacturing issues with one of its cardiovascular drug...