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FDA Wins Injunction Against Georgia Firm

[ Price : $8.95]

A federal court grants FDA an injunction against dietary supplement maker BioAnue Laboratories (Rochelle, GA) and its owners, Glor...

Sular Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Sular (nisoldipine) ER tablets were not withdrawn for reasons of safety or effectiven...

Hemoglobin A1c Test into Class 2

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Federal Register Final order: FDA classifies hemoglobin A1c test system into Class 2.

Recommendations for Creating Global Regulatory Coalition: Report

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A new report from the Council on Foreign Relations provides recommendations for FDA and its foreign counterparts as they move forw...

FDA Renews Advisory Committee Charters

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Federal Register Notice: FDA renews the charters of certain agency advisory committees.

FDA Approves Irokos Zorvolex for Osteoarthritis

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FDA approves an Iroko Pharmaceuticals supplemental NDA for Zorvolex (diclofenac) capsules, a nonsteroidal anti-inflammatory drug f...

FDA Targeting Informed Consent Revisions: Consultants

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Regulatory consultants firm the Weinberg Group says FDA will be paying close attention to the steps taken to revise clinical trial...

Eisai Files NDA for Seizure Drug

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Eisai files an NDA for its antiepileptic drug Fycompa (perampanel) as an adjunctive treatment for primary generalized tonic-clonic...

Senate HELP Committee Draft of Sunscreen Bill

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The Senate Heath, Education, Labor and Pensions Committee has released for public comment a draft bill that would require FDA to s...

Fusilev Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Fusilev injection 175 mg/17.5 mL and 250 mg/25 mL were not withdrawn for reasons of s...