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Safety Concerns Bring Boxed Warning to Genentechs Raptiva

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FDA announces labeling changes, including a Boxed Warning for Genentechs psoriasis drug Rapitiva.

FDA Seeks Helps Identifying BPA Products

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Federal Register Notice: FDA requests assistance in identifying types of FDA-regulated products containing Bisphenol A.

Panel to Discuss 2 NDAs for Skin Infections

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Federal Register Notice: FDAs Anti-Infective Drugs Advisory Committee will meet 11/18-20 to discuss a Theravance Corp.s NDA and a ...

Panel to Vote on Female Condom

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Federal Register Notice: FDAs Obstetrics and Gynecology Devices Panel will meet 12/11 to vote on a pMA from the Female Health Co. ...

Ethex Recalls 3 Lots of Dextroamphetamine

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Ethex recalls three lots of dextroamphetamine sulfate 5 mg tablets due to the possible presence of oversized tablets.

Altus Pancreatic Enzyme Petitions Mostly Denied

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FDA denies most requests in an Altus citizen petition on pancreatic enzyme drug products because it has not yet ruled on an Eurand...

FDA Orphan Status for Pancreatic Cancer Drug

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FDA grants an orphan drug designation for Reata Pharmaceuticals RTA 402, indicated for treating pancreatic cancer.

Reps Look at Bisphenol A Interest Conflicts

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Reps. Dingell and Stupak say they are broadening their BPA safety probe to include a potential advisory committee conflict of inte...

FDA Clears Amedica Spinal Implant

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FDA clears an Amedica 510(k) for the SEEplate Cervical Plate spinal implant system.

FDA OKs New Forteo Delivery Device

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FDA approves a new delivery device for Eli Lillys Forteo that is designed to help patients more easily administer their daily trea...