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FDA Files Closed-Door Panel Meeting Reports

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Federal Register Notice: FDA files with the Library of Congress the annual reports of FY 2007 closed-door advisory committee meeti...

Panel to Discuss Luitpolds Injectafer

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Federal Register Notice: FDAs Drug Safety and Risk Management Advisory Committee will meet 2/1/08 to discuss Luitpold Pharmaceutic...

FDA Revokes Another Fraudulent Device License

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The Seattle Times continuing expos of risky, unapproved medical device provokes further FDA action, this time against an illegal H...

No Prilosec or Nexium Increased Heart Risk

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FDA says its safety review of Prilosec and Nexium shows no increased risk of heart problems.

Better Science at FDA Means Raising Pay

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Consulting editor John Scharmann says recommendations to improve science at FDA depend on raising salary levels equally for field ...

FDA Clears BMeye Hemodynamic Monitor

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FDA clears a BMeye 510(k) for the Nexfin hemodynamic monitor.

FDA Says Requip for Parkinsons is Approvable

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FDA issues an approvable letter to GlaxoSmithKline for its restless legs syndrome drug Requip to be used in treating signs and sym...

DTC for Cypher Stent Questioned

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Investment advisor Brian Orelli says Johnson & Johnson should advertise its Cypher drug-eluting stent to doctors rather than consu...

Doctors, Patients Differ on Ulcerative Colitis

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Surveys of ulcerative colitis patients and their doctors sponsored by Shire show significantly differing perceptions on the diseas...

Possible New ESA Risk Cited

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Mayo Clinic researchers say Aranesp and other erythropoiesis-stimulating agents may cause a higher risk of leukemia in patients wi...