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Eisai Submits sNDA for Fycompa Monotherapy Use

[ Price : $8.95]

Eisai Inc. files a supplemental NDA for Fycompa (perampanel) seeking monotherapy use for treating partial-onset seizures with or w...

FDA Denies Abbott Petition Seeking Humira Biosimilar Block

[ Price : $8.95]

In approving an Amgen biosimilar for the first copy of Abbotts Humira (adalimumab) for multiple inflammatory diseases (see story),...

Rep. Fitzpatrick Seeks Hearing on FDA and Device Safety

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Rep. Mike Fitzpatrick (R-PA) asks the House Energy and Commerce Committee for a hearing to investigate FDAs failings over medical ...

Comments Extended on Advisory Committee Appearances Guide

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Federal Register Notice: FDA has extended the comment period until 11/26 for a guidance on Procedures for Evaluating Appearance Is...

Guidance on Generic Facility Self-Identification

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Federal Register Notice: FDA makes available a guidance on Self-Identification of Generic Drug Facilities, Sites, and Organization...

Wells Pharmacy Recalls Non-sterile Products

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Wells Pharmacy Network recalls all sterile human and veterinary products prepared since February due to an FDA concern over a lack...

Committee to Discuss Hypogonadism Drug Trial Designs

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Federal Register Notice: FDA announces a 12/6 meeting of its Bone, Reproductive and Urologic Drugs Advisory Committee that will di...

Fycompa Regulatory Review Period for Patent Extension

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Federal Register Notice: FDA detemines the regulatory review period for Eisais NDA for Fycompa (perampanel) that applies to a pate...

Myalept Regulatory Review Period for Patent Extension

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Federal Register Notice: FDA determines the regulatory review period for an Amylin Pharmaceuticals NDA for Myalept (metreleptin fo...

Belviq Regulatory Review Period for Patent Extension

[ Price : $8.95]

Federal Register Notice: FDA determines the regulatory review period for an Eisai NDA for Belviq that applies to a patent extensio...