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Multiple Issues in Acuvail Journal Ad

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CDERs Division of Drug Marketing, Advertising, and Communications says an Allegan journal ad for Acuvail contains unsubstantiated...

New Pediatrics Valcyte Dosing Guidance

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FDA issues revised pediatric dosing recommendations for Genentechs Valcyte to prevent overdosing of some pediatric patients.

Device Makers 'Troubled' by Device Review Performance

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Medical device industry representatives tell a public meeting that they are troubled by negative trends they are seeing in device ...

Forest Finalizes Federal Probe Agreement

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Forest says it will plead guilty to three charges and pay criminal and civil fines to end an investigation into activities involvi...

Advisors Split on Keeping Meridia Available

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An FDA advisory committee splits 50-50 on whether Abbotts controversial weight-loss drug should remain on the market.

New FDA Focus on Contract Manufacturers

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FDA drug and device speakers tell a joint PDA/FDA conference that the agency is paying stricter attention to contract manufacturer...

FDA Approves Savient Gout Drug

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FDA approves a Savient BLA for Krystexxa (pegloticase), indicated for treating gout in adults who do not respond to or tolerate co...

FDA Extends Review of AstraZeneca's Blood Thinner

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FDA extends by three months its review of an AstraZeneca NDA for blood thinner Brilinta (ticagrelor).

Advisors Nix Dextromethorphan Restrictions

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Members of FDAs Drug Safety and Risk Management Committee recommend that OTC products containing dextromethorphan not be classifie...

Ratio of Recalled PMA Devices Exceeds 510(k)s: Study

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A new study finds that there has been a lower percentage of 510(k) cleared devices recalled than PMA-approved devices since 1998.