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Insmed Plans Phase 3 Trial for follow-on Neulasta

[ Price : $8.95]

Insmed says it will use results from a planned Phase 1 clinical trial in the United Kingdom to propose a Phase 3 protocol agreemen...

Quality Problems at Bard Manufacturing Facility

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FDAs San Juan District Office warns C.R. Bard on significant quality problems at its manufacturing facility in Humacao, Puerto Ric...

Should Liability Cases be Referred to FDA?

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Law school professor Catherine Struve says it may be possible and useful for Congress to require courts to send product liability ...

FDA Clears VivaScope Skin Imager

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FDA clears a Lucid 510(k) for the VivaScope System, intended for use in providing physicians in vivo cellular resolution skin imag...

Company Defends Ortho Evra

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Ortho-McNeil-Janssen asks FDA to deny Public Citizens request that the Ortho Evra contraceptive patch be withdrawn from the market...

FDA Denies Bid to Block Letter Citing Stem Cell Therapy

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FDA rejects a citizen petition asking that it not publicly disclose an untitled letter citing promotional claims made on Regenerat...

More Info Sought on HDE Draft Guidance

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Medtronic says FDA should clarify several portions of its draft guidance on humanitarian device exemption regulations.

FDA Clears Intensive Care Unit Suitcase

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FDA clears an Integrated Medical Systems 510(k) for the MedEx 1000 suitcase intensive care unit.

FDA OKs Promotional Statements for Restylane

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FDA approves a Medicis PMA supplement to add clinical data statements to anti-wrinkle treatment Restylane, which the company plans...

FDA Clears Taxus Liberte Stent

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FSA clears Boston Scientifics Taxus Liberte drug-eluting stent.