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Panel to Discuss Potential Pediatric Products

[ Price : $8.95]

Federal Register Notice: FDAs Pediatric Oncology Subcommittee will meet 11/5 to the development of three products for potential pe...

FDA Clears New Hospira Infusion System

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FDA clears a Hospira 510(k) for the Sapphire infusion system.

FDA, Repros to Talk About Androxal Studies

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FDA tells Repros to request a teleconference to talk about clinical trials of its Androxal testosterone drug.

Priority Review for Lilly Gastric Cancer Therapy BLA

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FDA assigns a priority review for an Eli Lilly BLA for IMC-1121B (ramucirumab) as a single-agent treatment for advanced gastric ca...

FDA Approves Allergans Juvederm For Cheek Area

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FDA approves Allergans Juvederm Voluma XC, a dermal filler for temporarily correcting age-related volume loss in the cheek area in...

Codman and Shurtleff Pump Recall Class 1

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FDA says a recall of Codman and Shurtleff MedStream infusion pumps is Class 1.

FDA Completing Phase-out of CFC Inhalers

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FDA says its phase-out of medical inhalers with chlorofluorocarbon propellants will be completed by 12/31.

Correction on Fibromyalgia Meeting Comments

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Federal Register Notice: FDA corrects dates for submission of comments from a 9/23 Federal Register notice on a public meeting on ...

Panel to Discuss BioMarin BLA for Vimizim

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Federal Register Notice: FDAs Endocrinologic and Metabolic Drugs Advisory Committee will meet 11/19 to discuss a BioMarin BLA for ...

FDA Withdraws Certain Bexxar Indication

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Federal Register Notice: FDA withdraws an indication for GlaxoSmithKlines Bexxar because a postmarketing study that was a conditio...