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GUIDANCE DOCUMENT

Contents of a Complete Submission for the Evaluation of Proprietary Names April 2016

Download the Final Guidance Document
Final
Docket Number:
FDA-2008-D-0592
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance describes for industry the information that FDA uses to evaluate proposed proprietary names for certain drugs, including biological products, under the traditional review process within the time frames set out in Prescription Drug User Fee Act (PDUFA IV) performance goals. The review clock for the performance review goals begins when the Agency receives a complete submission (see
sections II. Background and III. PDUFA IV Goal Dates).
 

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All written comments should be identified with this document's docket number: FDA-2008-D-0592.

 
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