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ReGen Device Not Substantially Equivalent

[ Price : $8.95]

FDA says ReGens collagen scaffold is not substantially equivalent to existing Class 2 devices that have been cleared by FDA.

Cited in Court, Leiner Gets Warning Letter

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FDAs Atlanta District Office issues a Warning Letter to Leiner Health Products, noting it has suspended operations at facilities a...

FDA Wants Another Retaane Study

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FDA tells Alcon it wants another clinical study of Retaane for wet age-related macular degeneration.

FDA Clears Instrumentation Lab 510 (k)

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FDA clears an Instrumentation Laboratory 510(k) for HemosIL RecombiPlasTin 2 G, a prothrombin time reagent.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites F.H.G. Corp, Kunshan Chemical and Pharmaceutical, and Leiner Health Products.

Drug Safety Office Gets Deputy from NIH

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CDERs Office of Surveillance and Epidemiology hires Henry Skip Francis from the NIH Fogarty International Center as its deputy dir...

Supreme Court to Hear Rezulin Patent Case

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The U.S. Supreme Court agrees to hear Pfizers challenge to an appeals court decision that allowed a Michigan suit against its Rezu...

Baxter Recalls Upgraded Volumetric Pumps

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FDA says Baxter Healthcare is recalling Colleague infusion pumps because a service technician may not have completed required upgr...

How Drugs, Biologics Miss First-Cycle OKs

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CDER associate director for regulatory affairs Kim Colangelo identifies and analyzes factors that are statistically associated wit...

FDA Clears Sorin Annuloplasty Ring

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FDA clears the Sorin Group Memo 3D semirigid annuloplasty ring.