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Advocacy Groups Ask Stronger Chantix Warning

[ Price : $8.95]

Five consumer advocacy groups ask FDA for stronger labeling to describe adverse events associated with Pfizers Chantix.

Aeternas Macrilen Rejected by FDA

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FDA issues a complete response letter to Aeterna Zentaris citing reasons why its Macrilen cannot be approved as a means to evaluat...

FDA to Test Multiple Ebola Drugs Together

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FDA says it will use a new clinical trial protocol to speed development of Ebola drugs.

FDA, EMA Liaisons Help Their Agencies

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Former FDA liaison to the European Medicines Agency David Martin says it is important that the two regulatory bodies maintain a li...

OPDP Cites Misleading Sales Aid for Doral

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The CDER Office of Prescription Drug Promotion cautions Sciecure Pharma about false and misleading presentations in a Doral sales ...

FDA Collaborates on Multiple Myeloma Master Protocol

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FDA collaborates with the Multiple Myeloma Research Foundation, the National Cancer Institute, and other groups to accelerate the ...

Changes Highlighted in CDRH Device Recall Guidance

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King and Spalding attorney Pamela Forrest says FDA modified a draft guidance on medical device enhancements and recalls to elimina...

Regulatory Science and Review Enhancement MAPP

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CDER issues a MAPP on the Office of Translational Sciences management of the regulatory science and review enhancement program.

UFI System Specification Guidance

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An FDA guidance says the agencys preferred unique facility identifier for domestic and foreign drug establishments is the Data Uni...

FDA Denies Sodium Nitrate Standards Petition

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FDA denies a Hope Pharmaceuticals petition asking that companies filing NDAs or ANDAs for sodium nitrate or sodium thiosulfate dru...