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FDA Probing Perfusion CT Radiation Overexposure

[ Price : $8.95]

FDA says 206 CT perfusion imaging patients at one facility received greater-than-expected radiation doses in an 18-month period an...

Respiratory Viral Panel Assay into Class 2

[ Price : $8.95]

Federal Register Final rule: FDA classifies the respiratory viral panel multiplex nucleic acid assay into Class 2 with three guida...

Review Period Set for Lillys Entereg

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Federal Register Notice: FDA determines the regulatory review period for Eli Lillys Entereg for the purpose of patent extension.

Guidance on Modifications to Mammography Act

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Federal Register Notice: FDA releases a draft guidance, The Mammography Quality Standards Act Final Regulations: Modifications and...

GSK Reports Nebulized Relenza Death

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GlaxoSmithKline warns that its Relenza inhalation powder is not to be nebulized after a woman dies following treatment with a Rele...

FDA FY 2010 Budget Heads to Presidents Desk

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The House and Senate approve a conference committee report that sends FDAs FY 2010 appropriations bill to President Obamas desk fo...

FDA Complete Response on Spectrums Fusilev

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FDA issues Spectrum Pharmaceuticals a complete response letter on its NDA for Fusilev for injection, indicated for treating patien...

FDA Approves Berinert for Rare Genetic Diseases Symptoms

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FDA announces approval of CSL Behrings Berinert, the first treatment for acute abdominal attacks and facial swelling associated wi...

Potential Risks Identified in 13 Products in 1st Quarter

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FDA says that it identified potential signals of serious risks or new safety information in 13 drugs during the first quarter of t...

Device Registration, Listing Guidance Out

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CDRH issues a guidance on changes in the medical device registration and listing program.