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Info on Device Presubmission Program Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on a guidance on ...

FDA Asks Ariad to Suspend Iclusig Marketing

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FDA says Ariad has agreed to its request to suspend sales and marketing of Iclusig due to safety concerns.

Orphan Status for Stem Cell Therapeutics Leukemia Treatment

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FDA grants Stem Cell Therapeutics an orphan drug designation for the use of tigecycline in treating acute myeloid leukemia.

Actavis Sued Over ANDA for Generic Copy of Absorica

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Actavis files an ANDA seeking approval to market a generic copy of Ranbaxys Absorica (isotretinoin) capsules, and the company is s...

Feds Seeking Info on AstraZeneca PLATO Trial

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AstraZeneca says it has received a civil investigative demand from the U.S. Department of Justice seeking documents and informatio...

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...