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Info on Samples and Protocols Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on request for samples and protocols to the Office of Ma...

FDA Classifies Vision Aid into Class 2

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Federal Register Final order: FDA classifies the oral electronic vision aid into Class 2.

Safety Audit of FDA Labs Finds Areas for Improvement

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An HHS workgroup formed after smallpox vials were discovered in an FDA laboratory in 2014 completes an audit of the agencys labora...

Science Board Group Sees FDA Science Progress

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A Science Board subcommittee acknowledges FDA science improvements since a critical 2007 report and urges additional steps in the ...

DoJ Targeting Corporate Execs

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The Department of Justice says it is ramping up efforts to target corporate executives who break the law, rather than just their c...

FDA: Pearson Education Marketing Unapproved Device

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FDA warns Pearson Education that it is marketing its Quotient ADHD System without clearance or approval for the intended uses.

Dramatic Increase in Essure Adverse Events: FDA

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FDA tells an advisory committee it wants an open discussion about the heightened risks vs. the benefits of Bayers Essure female pe...

Be Vigilant in Clinical Research Compliance: Attorneys

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Attorneys Julie and Andrew Rusczek offer advice on mitigating risk of fraud and abuse violations in three common clinical research...

FDA Warning Letter Close Out for Bacterin International

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FDA issues a close-out letter related to a 2013 Warning Letter issued to Belgrade, MO-based Bacterin International.

FDA Clears B. Braun Medical Infusion Pump

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B. Braun Medical gains FDA 510(k) clearance for its second-generation, large-volume Infusomat Space Pump.