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Taken from the NEW Good Clinical Practice: A Question & Answer Guide 2010.  Order Here! 

Question: How does the FDA’s December 2009 industry guidance entitled, “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims” impact the acceptance of the use of subject diaries in the collection of patient-reported outcomes (PRO) during clinical trials?

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Barnett Releases Medical Device Development: Regulation and Law
September 15, 2009
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June 23, 2009
Barnett Announces it's First-Ever Clinical Trainer's Forum
April 15, 2009
Barnett releases new regulatory resource: IND: A Primer
March 2, 2009
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Download this podcast to hear more about Medical Device Development: Regulation and Law, the ''must-have'' resource for the novice or veteran medical device regulatory affairs professional. This practical reference provides the most comprehensive and updated analysis of US medical device and diagnostics development and approval requirements anywhere. This book also features in-depth analysis on how emerging developments and trends are reshaping medical device and combination product regulations in the US. The new edition of this popular and authoritative resource addresses the latest regulatory and legal developments that guide how medical devices are developed today.

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