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CDER 'Culture Shock' With 21st Century Review: Throckmorton

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CDER deputy director Douglas Throckmorton tells an industry meeting that Center managers are facing culture shock in trying to imp...

FDA Rejects Arena Weight-loss Drug; Requests More Data

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FDA issues a complete response letter to Arena Pharmaceuticals declining approval of the company's NDA for its weight-loss drug lo...

Generic Drug Industrys Jaeger Joins Pharmacy Group

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Former Generic Pharmaceutical Association CE Kathleen Jaeger is named the new head of the National Community Pharmacists Associati...

Grassley Quizzes Hamburg on FDA Conflict Rules

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Senate Finance Committee ranking member Charles Grassley asks FDA how far beyond the broad requirements of its regulations does it...

Comments Sought on Info on Dissolvable Tobacco Products

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Federal Register Notice: FDA seeks comments on an information request of tobacco companies to provide information on the use of di...

FDA Science Board to Meet

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Federal Register Notice: The Science Board to FDA will meet 11/15 to discuss items such as CDERs pharmacovigilance, comparative ef...

Essentialis, FDA Agree on SPA for High Triglycerides Treatment

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Essentialis, Inc. reaches agreement with FDA on a Special Protocol Assessment for a Phase 3 study for its diazoxide choline contro...

FDA OKs Roche HCV Test

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FDA approves Roches Cobas TaqMan HCV Test, v2.0 to quantify the amount of hepatitis C viral RNA in human plasma or serum of HCV-in...

FDA Approves REMS for Nuvigil/Provigil

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FDA approves a Risk Evaluation and Mitigation Strategies for Cephalon's Nuvigil (armodafinil) tablets and Provigil (modafinil) tab...

FDA Guidance on Drug Development Tool Qualification

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A new FDA guidance describes the qualification process for drug development tools, such as biomarkers and patient-reported outcome...