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FDA Approves Watson's Generic Keppra

[ Price : $8.95]

FDA approves a Watson Laboratories ANDA for a generic version of UCB's Keppra XR.

IMPROVE-IT Interim Analysis Delayed

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Merck says that a planned late 2011 interim analysis of efficacy data from its Vytorin IMPROVE-IT study will be delayed until the ...

Elan Adds Former Commish von E to Board

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Elan adds former FDA commissioner Andrew von Eschenbach to its board of directors.

ICH Guidance on Veterinary Residue Depletion Studies

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Federal Register Notice: FDA releases an ICH guidance on studies to evaluate the metabolism and residue kinetics of veterinary dru...

ICH Guidance on Validating Veterinary Drug Residue Analytical Methods

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Federal Register Notice: FDA releases a guidance on criteria found to be suitable for validating analytical methods used in veteri...

FDA Lifts Clinical Hold on Breast Cancer Vaccine

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FDA lifts a partial clinical hold against an RXi Pharmaceuticals Phase 3 clinical trial involving breast cancer vacccine NeuVax (...

FDA Approves Masitinib IND

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FDA approves an IND for AB Sciences Phase 3 study of masitinib to treat severe persistent asthma.

Comments Extended on Unapproved Sunscreen

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Federal Register Advance notice of proposed rulemaking: FDA extends the comment period on certain dosage forms of OTC sunscreen dr...

FDA, Xavier University Plan Global Outsourcing Conference

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Federal Register Notice: FDA Cincinnati District and Xavier University will co-sponsor a public conference 10/3-5 on improving glo...

FDA Supports Transcept Response Approach

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Transcept Pharmaceuticals says it was to meet 9/14 with FDA officials to discuss a regulatory path forward for its Intermezzo as a...