Pharmaceutical firms may participate in a voluntary two-year pilot program for the evaluation of proposed proprietary names to be conducted by FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. The pilot program will enable participating pharmaceutical firms to evaluate proposed proprietary names and submit the data generated from those evaluations to the FDA for review, as outlined in the FDA concept paper titled PDUFA Pilot Project Proprietary Name Review.
SOURCE: FDA Notice
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