CDER/CBER proprietary names meeting

Executive Summary

CDER and CBER will hold a public meeting June 5 to prepare for a pilot program on enabling pharmaceutical firms to evaluate proposed proprietary names and submit data generated from those evaluations to FDA for review (1"The Pink Sheet," Jan. 14, 2008, p. 15). The agenda includes a concept paper describing the logistics of the pilot program, proposed recommendations for carrying out a proprietary name review and the way FDA intends to review submissions. FDA plans to issue the concept paper by the end of this fiscal year and begin the pilot in FY 2009