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FDA Approves GE Imaging Agent

[ Price : $8.95]

FDA approves GE Healthcares AdreView, a molecular imaging agent for detecting rare neuroendocrine tumors.

Ranbaxy Seeks Help from Giuliani

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Ranbaxy hires former GOP presidential hopeful Rudy Giuliani to review FDA compliance issues from recent Warning Letters and an Imp...

ACCME Asked to Reconsider CME Changes

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Several affected industry groups suggest that much more study is needed before ACCME implements proposals to change CME funding an...

FDA Clinical Hold on Stem Cell Therapeutics Therapy

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FDA orders a clinical hold on enrolling patients in a Stem Cell Therapeutics Corp. Phase 2b stroke trial called REGENESIS in Canad...

Higher Deaths Reported in Some Procrit Stroke Patients

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Ortho Biotech says preliminary study findings in Europe show a higher mortality rate when Procrit is given off-label to ischemic s...

Phosphocol P 32 Leukemia Risk Cited

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Mallinckrodt says two pediatric leukemia cases have been reported in association with off-label intra-articular injection of its P...

CDRH Missteps Again: Who Vets the Vetters?

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Consulting editor John Scharmann reviews a new instance of CDRH management error in enforcement, compares it with others and concl...

FDA Struggles When Deciding to Issue Early Safety Alerts

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CDER Drug Safety Oversight Board (DSOB) executive director Steven Osborne discusses the challenges it faces when deciding whether ...

FDA Complete Response on Roches Arthritis Therapy

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FDA issues Roche a complete response letter for its BLA on Actemra (tocilizumab), indicated for treating rheumatoid arthritis.

FDA OKs Gore Endoprosthesis in Iliac Artery

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FDA approves W.L. Gores Gore Viabahn endoprosthesis for use in patients with symptomatic peripheral arterial disease in iliac arte...