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FDA Colluded with Industry to Write Cures Act: Group

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Public Citizen condemns senior FDA officials for colluding with the Advanced Medical Technology Association to help write legislat...

Comments Sought on Enhanced Transparency Submissions

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Federal Register Notice: FDA seeks comments on a proposed collection of information on interviews of pharmaceutical manufacturers ...

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...

Some Baclofen API May be Contaminated: FDA

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FDA cautions of potential serious risks associated with contaminated baclofen API manufactured

UK Firm Seeks Partner to Bring Ibuprofen Patch to FDA

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UK-based Medherant seeks a co-development partner to get FDA approval for worlds first-ever transdermal ibuprofen patch and others...

FDA Sets Review Period for Fulyzaq

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Federal Register Notice: FDA determines the regulatory review period for Napo Pharmaceuticals Fulyzaq for the purpose of patent ex...

Review Period Set for Sirturo

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

Review Period Set for Visual Stimulation System

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Federal Register Notice: FDA determines the regulatory for Second Sight Medical Products Argus II Visual Stimulation System for th...