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Panel to Discuss OTC Nasal Decongestants

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Federal Register Notice: FDAs Nonprescription Drugs Advisory Committee will meet 12/14 to discuss the safety and effectiveness of ...

Sanofi-Aventis Warned Over Ketek Trial

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CDER warns Sanofi-Aventis over failures to properly conduct a Ketek clinical trial.

Cephalon Updates Provigils Labeled Warnings

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FDA says Cephalon has updated Provigils (modafinil) labeled warnings to include information on serious rashes, including Stevens-J...

Enrollment Complete for Provenge Study

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Dendreon completes enrollment in a Provenge Phase 3 study needed to provide additional efficacy data to FDA.

Antibiotics Article Was Not Falsely Based

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Consulting editor John Scharmann replies to a critic who alleged there were two false premises in a recent article about animal an...

FDA OKs Suns Generic Exelon

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FDA approves a Sun Pharmaceutical Industries ANDA for a generic version of Novartis's Exelon caspsules, indicted for treating Alzh...

FDA Seeks Enrollment Stop in Delcath Trials

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FDA suggests a temporary enrollment suspension in Delcath System Phase 2 and 3 trials due to safety concerns.

FDA OTC Panel Turns to Decongestants

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FDAs Nonprescription Drugs Advisory Committee plans a 12/14 meeting to review re-formulated over-the-counter oral nasal decongesta...

Ex-FDAer Peg ORourke Joins Drug Consulting Firm

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Former FDA drug marketing regulator Margaret Peg ORourke joins the French drug industry consulting firm of Cegedim Dendrite.

Ortec Submits Final Data on OrCel PMA

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Ortec International s submits final PMA modules on safety and efficacy data for OrCel, intended for use in treating venous leg ulc...