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FDA Panel Splits on Vytorin in Kidney Disease Patients

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FDA's Endocrinologic and Metabolic Drugs Advisory Committee splits with its vote to recommend an expanded indication for Vytorin w...

Autor: In Global Economy, FDA Must Abandon Go It Alone

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Deputy commissioner for global regulatory operations and policy Deborah Autor asserts that globalization requires FDA to abandon i...

Make Medical Ghost Writing Illegal: Professors

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Two University of Toronto professors say RICO provisions should be used to punish those who fraudulently sign their names as autho...

FDA Lifts Clinical Hold on Pancreatic Cancer Therapy

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FDA lifts a partial clinical hold against an Immunomedics clinical study involving clivatuzumab tetraxetan in patients with advanc...

FDA Approves TriVascular Abdominal Stent System

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FDA approves the TriVascular Ovation abdominal stent system as a Humanitarian Use Device.

Edwards Sapien Heart Valve Approved

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FDA approves an Edwards Life Sciences PMA for the Sapien Transcatheter Heart Valve, the first such device that can replace an aort...

Endo Pharma Generic Plendil Approved

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FDA approved an Endo Pharmaceuticals ANDA for a generic copy of Plendil extended-release tablets.

Revised Guidance on Residual Solvents in New Animal Drugs

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Federal Register Notice: FDA releases a revised ICH guidance on acceptable amounts of residual solvents in new animal drugs.

FDA Issues Q&A on 3 IHC Guidances

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FDA issues a question and answer guidance to clarify issues that arisen in implementation of three ICH drug guidances.

Study Finds No ADHD Drug/Cardiovascular Event Association

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FDA says results of a large study show no association between use of ADHD drugs in children and young people and an increased risk...