Issue Date: April 11, 2016
Issued by: Center for Drug Evaluation and Research
Topic(s): Labeling, Safety – Issues, Errors, and Problems
Status: Final
Contents of a Complete Submission for the Evaluation of Proprietary Names
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).
Download the Guidance Document
