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FDA Accepts Telemonitoring for Lisinopril MS Trial

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FDA approves a Phase 2a IND trial of lisinopril for treating multiple sclerosis using telemonitoring instead of most patient trial...

Group Says Hamburg Gave Inaccurate Testimony on Compounding

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Public Citizen says FDA commissioner Margaret Hamburg provided inaccurate testimony about pharmacy compounding last month during C...

FDA Clears Avinger Imaging Catheter

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FDA clears an Avinger 510(k) for its Ocelot PIXL imaging catheter with onboard imaging for crossing chronic total occlusions in pa...

New Medical Device Tax Will Cut Workforce: Survey

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AdvaMed members surveyed say the medical device tax taking effect 1/1/13 will lead to layoffs or reduced hiring.

2 New Site Data Submission Guidances

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FDA issues guidances to help NDA and BLA sponsors submit summary level clinical site datasets in a standardized electronic format.

Amgen to Pay $762 Million to Settle Aranesp Marketing Suit

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Amgen says it is waiting for judicial approval of its agreement to pay $762 million to resolve civil and criminal charges that it ...

Glaxo, Theravance NDA for COPD Drug

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GlaxoSmithKline and Theravance file an NDA for their investigational once-daily LAMA/LABA combination medicine for patients with c...

5 LASIK Doctors Warned About Advertising

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FDA warns five eye care providers about LASIK advertising that doesnt give consumers sufficient risk information.

Quality System Violations in Wearable Therapy Production

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FDAs Detroit District Office warns Axiobionics about Quality System and other violations in its manufacturing of electrical stimul...

FDA Says Oregon IRB Failed to Protect Human Subjects

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FDA warns the Salem, Oregon, Hospital IRB about violations of the law and regulations that protect human research subjects.