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Cubist to Initiate Phase 3 Trials for C. Difficile Product

[ Price : $8.95]

Cubist Pharmaceuticals plans Phase 3 clinical trials of its therapy to treat Clostridium difficile-associated diarrhea.

FDA Targets 717 Web Sites in Illegal Marketing Operation

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FDA and other regulatory and international partners complete a week-long Internet crackdown on producers and distributors of count...

FDA Clears 2 Army Influenza Test Kits

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FDA clears U.S. Army Office of the Surgeon General 510(k)s for two Influenza test kits and their use with Idaho Technology's Joint...

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 Determines Discovery Labs Response on Surfaxin Complete

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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

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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.