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FDA Clears Neo Dental Cavity Fillers

[ Price : $8.95]

FDA clears a Neo Dental International 510(k) for the Cavios Cavity Liner product and Evadyne Temporary Resin product.

Government Seeking More Healthcare 'Exclusions'

[ Price : $8.95]

FDA's Ric Blumberg and HHS' Greg Demske lay out the case for why the U.S. government has recently increased its efforts to exclude...

FDA Determines Discovery Labs Response on Surfaxin Complete

[ Price : $8.95]

FDA declares complete a Discovery Laboratories response to the agencys complete response letter on Surfaxin, an investigational dr...

Info on Prescription Drug Marketing Act Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information on the reporting and recordkeeping requirements containe...

Guidance on Animal Drug Safety & Effectiveness Protocols

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Federal Register Notice: FDA releases a guidance on target animal safety and effectiveness protocol development and submission.

Guidance on Time and Extent Applications for OTC Drugs

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Federal Register Notice: FDA releases a guidance on time and extent applications for nonprescription drug products.

FDA Warns 2 Net Marketers

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FDA warns two Internet marketers using hundreds of Web sites to market unapproved and misbranded prescription drugs.

CSL Says No New FDA Warnings

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CSL Biotherapies says it has received no new FDA warnings for its influenza vaccine manufacturing facility in Australia.

CDRH Changes How Clinical Data Requests are Evaluated: Shuren

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CDRH director Jeff Shuren tells AdvaMed 2011 that device reviewers need to clear with the Center Science Council any requests to r...

FDA Clears Amcom Messenger

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FDA clears Amcoms Messenger middleware secondary notification system.