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FDA Cancels Amarin Special Protocol Assessment

[ Price : $8.95]

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...

FDA Clears Tria Beauty Age-Defying Laser

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FDA clears a Tria Beauty 510(k) for its over-the-counter Age-Defying Laser and its use to reduce wrinkles.

FDA Orphan Drug Status for Joint Infection Therapy

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FDA has granted Cempra an orphan drug designation for Taksta (CEM-102) for treating prosthetic joint infections.

FDA Wants Lab Data in Systme International Unit Standards

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CDER and CBER consider requiring laboratory data in clinical trials that are measured and reported in Systme International units i...

FDA Working on Mammography Regulation Amendments

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FDA denies a petition seeking enforcement of mammography regulations and says it is developing proposed amendments to the regulati...