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Drop Waxman-Hatch Generics Incentive: Researchers

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The Generic Pharmaceutical Association blasts research funded by Pharmaceutical Research and Manufacturers of America calling on C...

FDA Grants Fast Track for MS Therapy

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FDA grants Opexa Therapeutics fast track status for tovaxin and its use in treating patients with secondary progressive multiple s...

Rothenberg Permanently Debarred

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Federal Register Notice: FDA issues an order permanently debarring Gayle Rothenberg from providing services to anyone with an appr...

Comments Extended on Device Modification Guidance

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Federal Register Notice: FDA reopens the comment on a draft guidance on 510(k) device modifications.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites International Isotopes and SterilMed.

CGMP Violations Found at International Isotopes

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FDAs Seattle District Office warns International Isotopes about CGMP problems in manufacturing a radiopharmaceutical and marketing...

Make Medical Device Approval Changes: Caucus

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Members of the Congressional Medical Technology Caucus ask FDA commissioner Margaret Hamburg to make four specific changes to the ...

FDA Clears Mobile Medical Image Viewer

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FDA clears a Carestream 510(k) for the Vue Motion medical image viewer and its use with mobile devices such as Apple iPads.

Mylan Sued On Proposed Generic Orapred

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Shionogi Pharma and Cima Labs file a patent infringement suit against Mylan Pharmaceuticals over an ANDA it submitted for a generi...

Changes are Coming in FDA Field Capabilities

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Consulting editor John Scharmann reports on current expansion of FDAs field staff and investigational capabilities.