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FDA Orphan Status for Vivendy Enzyme Replacement

[ Price : $8.95]

FDA grants Vivendy Therapeutics orphan drugs status for its enzyme replacement therapy, indicated for treating mucopolysaccharidos...

Lipitor Ads Likely Misleading to Women

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Researchers fault FDA for not adequately policing Pfizer ads and labeling for Lipitor.

Guidance on Urinary Incontinence Devices

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Federal Register Notice: FDA releases a draft guidance on clinical investigations of devices indicated for treating urinary incont...

Guidance on Genetically Engineered Animals

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Federal Register Notice: FDA releases a draft guidance on the regulation of genetically engineered animals containing heritable rD...

FDA Clears Solx Laser for Glaucoma

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FDA clears a Solx 510(k) for the Solx 790 laser, intended for use in performing titanium:sapphire laser trabeculoplasty (TLT) in g...

Safety Concerns on 4 Drugs in FDA Newsletter

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FDAs latest Drug Safety Newsletter covers concerns found in Lariam, Revlimid, Cordarone and Pacerone, and Extraneal.

Dingell Probing Centrum Cardio Ad Claims

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Attorney Cassandra Soltis questions how Reps. Dingell and Stupak will determine if ad claims for Wyeths Centrum Cardio multi-vitam...

Technical Amendments Corrected

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Federal Register Final rule: FDA corrects an 8/25 Federal Register final rule that made technical amendments to CBER and CDRH regu...

Biologics Structured Product Labeling Workshop Slated

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Federal Register Notice: FDA plans a public workshop 11/17 on structured product labeling for the biologics industry.

FDA Orphan Status for Enobia Hypophosphatasia Therapy

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FDA gives Enobia Pharma an orphan drug designation for ENB-0040, an enzyme replacement therapy for hypophosphatasia.