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FDA Needs CV Info on Alogliptin-Actos Combination

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FDA says it needs cardiovascular outcome safety information on Takedas proposed fixed dose combination of alogliptin and Actos.

FDA Approves New Zevalin Indication

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FDA approves a new indication for Spectrums Zevalin to treat some categories of patients with previously untreated follicular non-...

Info on Data Sources for the Sentinel Initiative

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Federal Register Notice: FDA submits a proposed collection of information on the evaluation of potential data sources for the Sent...

Review Period Set for Banzel

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Federal Register Notice: FDA determines the regulatory review period for Novartis Banzel for the purpose of patent extension.

Doribax Review Period Set

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Federal Register Notice: FDA determines the regulatory review period for Ortho McNeils Doribax for the purpose of patent extension...

Review Period Set for Medtronics Talent System

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Federal Register Notice: FDA determines the regulatory review period for Medtronics Talent Abdominal Stent Graft System.

Postmarket Annual Report Available

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Federal Register Notice: FDA releases its annual report on the status of postmarketing requirements and commitments for approved d...

Are Safety Concerns Causing a Drug Approval Lag at FDA?

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An Institute of Medicine drug safety meeting discusses a potential drug approval lag reemerging at FDA due to drug safety concerns...

FDA to Review BMS Belatacept BLA

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FDA accepts for filing and review BMS belatacept BLA for use in kidney transplants.

Latest FDA Inspection Reports Posted

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FDA Webview posts to our site FDA inspection documents we have received from FDA pursuant to our FOI requests. They are for Actigr...