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Correction in Orphan Products Grant Program Notice

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Federal Register Notice: FDA corrects date error in an 8/6 Federal Register notice on the availability of grant funds from FDAs Of...

Location Announced for Devices User Fee Meeting

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Federal Register Notice: FDA releases the exact location of the public meeting on the reauthorization of the medical device user f...

Correction in Device Nanotechnology Meeting Notice

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Federal Register Notice: FDA corrects a Web address in an 8/23 Federal Register notice announcing a public workshop on medical dev...

FDA Publishes Analytical Sieving Text Info

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FDA publishes an ICH annex on interchangeable pharmacopeial texts related to analytical sieving.

FDA Reminds Practitioners About Tygacil Mortality Risk

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An FDA drug safety communication says the agency has documented an increased mortality risk associated with using Pfizers Tygacil....

Allergan Settles Botox Marketing Case for $600 Million

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Allergan says it will pay $600 million and plead guilty to one misdemeanor count to resolve a federal investigation into its off-l...

Pfizer Sues Mylan Over Chantix ANDA

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Pfizer files a patent infringement suit over Mylans ANDA for generic Chantix.

FDA Approves First-line Use for Allergan Glaucoma Drug

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FDA approves Allergans Lumigan (bimatoprost ophthalmic solution) 0.01% as a first-line therapy indicated for reducing elevated int...

FDA Clears InfraReDx Coronary Imaging System

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FDA clears an InfraReDx 510(k) for the LipiScan IVUS Coronary Imaging System, a cardiac catheter intended to help cardiologists id...