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Review Period Set for Eliquis

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Federal Register Notice: FDA determines the regulatory review period for Bristol-Myers Squibbs Eliquis for the purpose of patent e...

FDA Panel Backs Teva Asthma Drug in Adults

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An FDA advisory committee votes 11 to 3 to recommend approval of a Teva Pharmaceutical Industries BLA for Cinqair (reslizumab) for...

Hearing Mulls Priority Review for Generics to Curb Prices

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Johns Hopkins Bloomberg School of Public Health professor Gerard Anderson tells a Senate hearing that Congress should consider cre...

Wording Changes Help Risk Info Comprehension: Study

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An FDA-funded study demonstrates that consumers gain a better understanding of drug safety risk communications when they follow pl...

FDAers Defend Flibanserin Approval

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FDA staffers describe the process the agency followed in first rejecting and then approving Sprouts flibanserin for treating femal...

CDRH Compliance Shifting the Way it Monitors Industry

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CDRH Office of Compliance (OC) acting director Sean Boyd says OC has several initiatives under way to shift the way it monitors or...

FDA Withdraws Approval of NADAs/ANADAs

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Federal Register Notice: FDA withdraws approval of two NADAs/ANADAs that are no longer marketed.

Medtronic PMA Approved to Allow MRIs with Neurostimulators

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FDA approves a Medtronic PMA to allow full-body magnetic resonance imaging (MRI) procedures for patients using Activa Deep Brain S...

Pharmalucence Seeks Tougher Stance on Compounders

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Sun Pharmas Pharmalucence urges FDA to take corrective actions to ensure that compounding pharmacies and outsourcing facilities th...

Physicians Challenge FDA Risk Assessment on Morcellators

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A group of 49 physicians from the Leiomyoma Morcellation Review Group disagree with FDA restrictions and a safety alert on the use...