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Sorry, No Written Agreement on 'Phantom Recall' J&J Says

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Lawyers representing Johnson & Johnson admit that there was no formal agreement with FDA to use an outside contractor to visit ret...

Mylan's Generic Prograf Approved by FDA

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FDA approves a Mylan Pharmaceuticals ANDA for a generic version of Astellas' Prograf capsules used in preventing organ transplant ...

White Paper Raises FDA Monoclonal Antibody Questions

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Parexel Consulting says companies developing follow-on biologics are interested in how FDA will treat monoclonal antibodies.

FDA Approves Gilenya for MS Relapses

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FDA approves Novartis Gilenya for reducing multiple sclerosis relapses and delaying disability progression.

Gen-Probe PMA for Prostate Cancer Assay

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Gen-Probe files a PMA for its Progensa PCA3 assay, a new molecular test that may help determine the need for repeat biopsies in me...

Comments Sought on DTC Drug Ad Promos

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Federal Register Notice: FDA seeks comments on a study of the effects of promotional offers in DTC prescription drug print ads on ...

Comments Sought on Third-Party Device Review

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Federal Register Notice: FDA seeks comments on requirements for the information collection in Medical Devices Third-Party Review u...

ICH Prep Meeting Scheduled

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Federal Register Notice: FDA plans a public meeting 10/13 as preparation for the upcoming ICH steering committee and expert workin...

Safe-Use Initiative Workshop Planned

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Federal Register Notice: FDA plans a public workshop 11/16-17 on the Safe Use Initiative, established to reduce preventable harm f...

Documents Show J&J Was Aware of Ortho Evra Risks

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An NBC Today show report says company documents indicate that Johnson & Johnson was aware that its Ortho Evra birth control patch ...