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House Passes Temporary FDA Budget

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The U.S. House of Representatives votes 235-162 to pass a short-term FDA budget to allow furloughed employees to return to work, b...

FDA Cancels Merck BLA Advisory Panel Review Due to Shutdown

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FDA cancels an 11/6 Allergenic Products Advisory Committee meeting that was set to review Mercks BLA for Grastek, a Timothy Grass ...

FDA Clears Advanced Catheter for Occlusion Perfusion Catheter

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FDA clears an Advanced Catheter Therapies 510(k) for its Occlusion Perfusion Catheter.

Inspection Finds QS Violations at Japans Nidek Company

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FDA warns Japans Nidek Co. about Quality System violations in its manufacturing of non-sterile laser devices.

Boston Scientific Catheter Scores Well in Clinical Trial

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Boston Scientific says a clinical trial of its OffRoad Re-entry catheter system performed better than pre-specified trial goals.

FDA Probing Hepatitis Cases Linked to OxyElite Pro

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FDA says it is working with CDC and the Hawaii Health Department to investigate cases of acute non-viral hepatitis in Hawaii that ...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Anji Zheng Bang Medical Instruments, Batrik Medical Mfg., and Nidek Co.

FDA Accepts Keryx NDA for Zerenex

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FDA accepts for review a Keryx Biopharmaceuticals NDA for Zerenex (ferric citrate coordination complex) for use in patients with c...

Cubist Pharma: New Molecules Active Against Superbugs

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Cubist Pharmaceuticals and Spains Fundacin MEDINA say they have discovered a new family of natural molecules that have shown activ...

Look at How Policies Affect Drug Development: PhRMA

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PhRMA president John Castellani says its important to consider how public policies may affect patient care and drug development in...