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FDA Approves Glaxos Promacta

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FDA approves GSKs Promacta for treating thrombocytopenia in patients with chronic immune thrombocytopenic purpura.

FDA Panel Backs New Use for Navistar Catheter

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FDAs Circulatory System Devices Panel unanimously recommends approval of a Biosense Webster PMA supplement for the Navistar Thermo...

FDA Asked to Act on Dental Imports

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Sen. Sherrod Brown asks FDA for information on agency standards and activities involving lead-contaminated dental implants.

FDA Posts Guidance on Drug Proprietary Names

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FDA releases a draft guidance to provide recommendations to NDA, BLA and ANDA sponsors on proprietary name submissions.

Grassley Asks Vendor for Off-label Info

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Sen. Chuck Grassley asks a drug company services vendor if it has helped companies disseminate information on off-label uses of an...

Super Bugs on the Loose!

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Consulting editor John Scharmann questions CVMs continuing practice of approving food-animal antibiotics even as new super bugs em...

FDA Accepts BLA for Dyax Angioedema Therapy

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FDA accepts for review a Dyax Corp. BLA for DX-88 (ecallantide), indicated for treating acute hereditary angioedema attacks.

FDA Probing Doc Understanding of Drug Effectiveness

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FDA says it will research how two groups of doctors learn about drug effectiveness for treating insomnia and arthritis.

Accelerated Approval to Prevent Sucraid Shortage

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FDA accelerates approval of manufacturing changes to QOL Medicals Sucraid to prevent drug shortages.

Nubain Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Nubain injection, 10 and 20 mg/ml was not withdrawn from sale for reasons of safety a...