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CDRHs 3 Top Goals Described

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CDRH Office of Device Evaluation acting associate director Thinh Nguyen identifies the Center activities that will receive emphasi...

Pennsylvania Residents Ask About Advertised Drugs

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Nearly half of Pennsylvania adults surveyed say they have a drug or medical procedure they saw advertised.

Why FDA Leniency for Deficient Chinese Drug GMPs?

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Consulting editor John Scharmann questions the leniency shown by FDA toward a Chinese manufacturer found with significant GMP devi...

Cabinet X-ray Compliance Guide Out

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CDRH publishes compliance guide for cabinet x-ray systems.

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.

CDER Rolls Out New Application Review Process

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CDER Office of New Drugs deputy director Sandra Kweder unveils an improved process for application reviews.

ReGen Device Not Substantially Equivalent

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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...