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Higher CV Risk Seen in Chantix Patients

[ Price : $8.95]

FDA says a higher occurrence of major adverse cardiovascular events was observed in patients using Pfizer's smoking cessation aid ...

FDA Accepts Takeda/Lundbeck NDA for Brintellix

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FDA accepts for review a Takeda and H. Lundbeck NDA for Brintellix for treating major depressive disorder in adult patients.

Advisors Asked About Drug Teratogenic Risk

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FDA releases discussion points on managing drug teratogenic risk for a rescheduled meeting of the Drug Safety and Risk Management ...

CDER Staff Worried About Late-Cycle Meetings: Jenkins

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CDER Office of New Drugs director John Jenkins says his staff are worried about the outcomes from the addition of late-cycle meeti...

FDA Approves Sucampo sNDA for Rescula

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FDA approves a Sucampo Pharmaceuticals supplemental NDA for Rescula 0.15% for lowering intraocular pressure in patients with open-...

FDA Releases Celltex Therapeutics Inspection Results

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FDA releases the FDA-483 containing 14 inspection observations issued after an April inspection at Celltex Therapeutics.

Natus Medical Olympic Cool-Cap System Recall is Class 1

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FDA says the Natus Medical recall of the Olympic Cool-Cap System due to the potential for unexpected power failure and lack of coo...

Product Design Safety Consideration Draft Guidance Out

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FDA publishes a draft guidance to help drug sponsors minimize medication errors relating to drug product design.

Mylan Wants FDA to Deny Valeant Zovirax Petition

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Mylan calls on FDA to deny a Valeant petition asking that the agency require clinical endpoint studies for any ANDA for generic Zo...

Milo Biotech Orphan Status for Muscular Dystrophy Drug

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FDA grants Milo Biotechnology an orphan drug designation for AAV1-FS344 for treating Becker and Duchenne muscular dystrophy.