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Complete Response, Harmonization, INDs Rank On FDA Regulatory Agenda

Executive Summary

Complete response: FDA plans to finalize its proposed rule to replace "approvable"/"not approvable" letters in response to NDAs with complete response letters in October, according to HHS' spring "unified agenda." The rule is intended to fulfill the 1997 FDA Modernization Act requirement to discontinue "approvable"/"not approvable" letters in favor of a standard format. While complete response letters will still identify deficiencies in an application, they are believed less likely to create overreaction by investors. The proposed rule was issued in July 2004 (1"The Pink Sheet" July 26, 2004, p. 10)...

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