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FDA Wants to Study Adolescents Reactions to DTC Drug Ads

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FDA solicits comment on a plan to research how adolescents respond to risk and benefit information in DTC drug ads marketed to the...

FDA Cancels Amarin Special Protocol Assessment

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FDA rescinds an Amarin study special protocol assessment agreement for Vascepa (icosapent ethyl) capsules after it determined that...

Orphan Drug Designation for KaloBios Monoclonal Antibody

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FDA grants KaloBios Pharmaceuticals an orphan drug designation for KB001-A, an anti-PcrV monoclonal antibody fragment for treating...

Law Firm Continues to Press Risperdal Pediatric Concerns

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Attorney Stephen Sheller urges FDA to use its power to obtain documents on risperidone pediatric safety from Johnson & Johnson.

Panel to Discuss Amylin Pharmas Metreleptin

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Federal Register Notice: FDAs Endocrinologic and Metabolic Drugs Advisory Committee will meet to discuss Amylin Pharmaceuticals BL...

Panel to Discuss 2 BLAs for Crohns Disease, Colitis

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Federal Register Notice: FDAs Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee...

FDA Accepts Afrezza NDA Resubmission

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FDA accepts for review a MannKind NDA resubmission for Afrezza (insulin human [rDNA origin]) inhalation powder, indicated for impr...

Policies Needed for Advisory Panel Interest Conflicts: Public Citizen

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Public Citizen Health Research Group founder Sidney Wolfe says FDA must immediately improve ethics training for advisory committee...

Results of Large Clinical Trials Often Unpublished

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Researchers writing online in the BMJ say too few large clinical trials are publishing results in peer-reviewed journals or postin...

Coalition Advances More Ways to Foster Combination Products

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The Combination Products Coalition gives FDA additional recommendations on ways to speed guidance to encourage development of inno...