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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...

Group Writes Hamburg on Gardasil Approval Mistake

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Non-profit advocacy group S.A.N.E. Vax complains in a letter to FDA commissioner Margaret Hamburg that the agency mistakenly allow...

Pharma Companies Lead 'False Claims' Settlements

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Public advocacy group Taxpayers Against Fraud reports that the eight of the top 10 whistleblower settlements in fiscal year 2010 u...

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...

Novartis Plans BLA to Expand Use of Menveo Vaccine

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Novartis says it will submit a supplemental BLA by year end on its Menveo meningococcal quadrivalent conjugate vaccine for an expa...

Amphastar Alleges Vindictive FDA Actions on Heparin

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Amphastar Pharmaceuticals files suit in DC federal court against FDA, alleging illegal detention of two shipments of raw heparin f...