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Plan B Decision Could Lead to Intermediate Pharmacy System: FDAer

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CDER Office of New Drugs director John Jenkins tells an industry conference that HHS' decision to override an FDA review conclusio...

Strengthen Yasmin Labeling: Advisors

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Members of two FDA advisory committees say that Bayers Yasmin contraceptives are effective but need stronger labeling wording on a...

On Plan B, the Time of Truth Is Nigh

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Washington commentator Robert F. Steeves sees HHS commentator Kathleen Sebelius over-ruling of FDAs Plan B decision as a denial of...

CDRH Compliance Office Outlines 'Next Steps' to Improve Quality

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CDRH Office of Compliance director Steve Silverman outlines his office's next steps to properly align its regulatory approach towa...

Foreign Drug Inspections See Lab Control Problems, FDA Says

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CDER Office of Manufacturing & Product Quality associate director Rick Friedman tells FDLI that the agency is concerned about labo...

FDA Program Begins Testing Compounds for Toxicity

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A high speed robotic screening system named Tox21, a collaboration of FDA, NIH, and EPA, today begins testing a library of 10,000 ...

KV Pharmaceuticals Paying $17 Million in Whistleblower Case

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The Justice Department says that KV Pharmaceuticals is paying $17 million to resolve False Claims Act whistleblower charges agains...

FDA Documents Failures at Ben Venue Quality Unit

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FDA releases the FDA-483 documenting significant and pervasive quality problems at the now-closed Ben Venue drug manufacturing fac...

CooperVision Lens Recall is Class 1

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FDA says CooperVisions recall of Avaira Sphere contact lenses is a Class 1 recall.

FDA Denies Request for ED Drug Warning, Other Safety Steps

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FDA denies a Public Citizen request for a Boxed Warning, Medication Guides, Dear Doctor letters, and a patient registry for erecti...