FDA Prioritizes Priority

Executive Summary

FDA's Office of New Drugs issues policy to expedite an NDA, BLA or efficacy supplement classification. The revised review classification policy now directs divisions to identify whether an application may qualify for a priority designation within 14 days of an application's receipt. If a priority designation is expected, the filing meeting to determine the review classification and first-cycle review timeline should occur by day 30 instead of day 45, the standard review date, a July 16 1Manual of Policies and Procedures states...