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FDA refuse-to-file policy

Executive Summary

"So far this year, only one of the 22 NMEs received have been refused to file," CDER Acting Director Gerald Meyer tells PMA's Medical Section Regulatory Affairs Committee Nov. 16. "This is a drastic reduction" from previous years, where RTFs have been running at about 14% of NMEs, Meyer says. Refuse-to-file actions on all NDAs are down to 19% from an average of 25%. The number of IND holds also has decreased. So far this year, FDA has placed holds on 8% of the 953 INDs received compared to 12% of 1,164 INDs put on hold in 1992.
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