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FDA Proposes Drug Shortages Rule

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Federal Register Proposed rule: FDA proposes to require certain drug/biologic manufacturers to notify it electronically of a disco...

Curemark Begins Rolling NDA for Autism Therapy

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Curemark says it has begun an NDA rolling submission for CM-AT, the companys enzyme replacement therapy for autism treatment.

Invega Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Invega extended-release tablet, 12 mg was not withdrawn for reasons of safety or effe...

Panel to Discuss 2 Grass Allergy Tablets

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Federal Register Notice: FDAs Allergenic Products Advisory Committee will discuss Stallergenes Oralair and Mercks Grastek for gras...

Perrigo Recalls 18 Lots of Infant Liquid Acetaminophen

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Perrigo recalls 18 lots of its acetaminophen infant suspension liquid, 160 mg/5 mL, sold in 2 oz. and 4 oz. bottles with syringes.

Study Shows Opioid Drugs Increase Depression Risk

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A new study shows that opioid pain killers can increase the risk of developing major depression.

Mylan Sued Over ANDA for Generic Uloric

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Teijin Limited and Takeda Pharmaceuticals sue Mylan in connection with an ANDA submission for a generic copy of Uloric (febuxostat...

FDA Approves IGI Labs Site Transfer for Econazole Cream

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FDA approves an IGI Laboratories site transfer to move econazole nitrate cream 1% manufacturing to the companys facility in Buena,...

First Breakthrough Designated Drug OKd Genentechs Gazyva

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FDA approves the first breakthrough-designated drug a Genentech BLA for Gazyva (obinutuzumab) for use in combination with chloram...

Court Rules in Favor of Whistleblower Alleging FDA Non-Compliance

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The 11th Circuit Court of Appeals vacates a lower court decision that granted Bausch & Lomb summary judgment in a GMP non-complian...