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Rejected Out of Hand: FDA "Refuse-to-File" Letters Hit Five-Year High

This article was originally published in RPM Report

Executive Summary

Refuse-to-file letters used to be extremely rare events, but as FDA data show, that's not necessarily the case anymore. In fiscal years 2003 through 2005, FDA issued no more than four refuse-to-file letters, with three such actions taken in 2004. But in 2006 and 2007, the numbers rise sharply; FDA sent seven letters in 2006 and 11 letters, including one for a biologic application, last year.

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