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Incorrect Labeling Causes Medtronic Class 1 Catheter Recall

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FDA says that a Medtronic letter to doctors about the incompatibility of its Sutureless Connector intrathecal catheters with IsoMe...

FDA Reviewing Exjade Adverse Events

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FDA says it is looking into the possibility that patients with myelodysplastic syndrome are at greater risk for Exjade adverse eve...

FDA OKs First Drug for Peripheral T-cell Lymphoma

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FDA approves Allos Therapeutics Folotyn, the first drug for treating Peripheral T-cell Lymphoma.

Risks Communication Panel to Meet

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Federal Register Notice: FDAs Risk Communication Advisory Committee will meet 11/12 to discuss strategies designed to communicate ...

Hearing Opportunity on Proposed NDA Withdrawals

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Federal Register Notice: FDA announces an opportunity to request a hearing on the agencys proposal to withdraw approval of five ND...

Priority Review for Nuvigil sNDA

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FDA says it will give a priority review to Cephalons sNDA for Nuvigil as a treatment to improve wakefulness in patients with exces...

Court Blocks Teva Generic Evista Launch

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A federal court upholds four Lilly Evista method-of-use patents and orders Teva not to launch its generic form of the drug.

Dendreon to Submit Amended Provenge BLA in November

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Dendreon says it is about six weeks away from resubmitting its controversial BLA for Provenge (sipuleucel-T), indicated for treati...

Internists See 6 Steps to Improved Drug Regulation

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The American College of Physicians says that FDA needs more funding and other changes to be able to meet its mandate of regulating...

Groups Want Biosimilars Pathway in Reform Bill

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27 patient advocacy groups tell Congress they want a biosimilars regulatory pathway amended into the healthcare reform legislation...