ANDAs Can Get Priority, Eight-Month Reviews Under User Fee Deal
Executive Summary
GDUFA II gives certain generics the possibility of an even faster review clock, which burnishes FDA's credentials in the drug pricing debate, but in order to take advantage, applications will need to be of high quality in addition to addressing a public health priority.
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Performance numbers are likely to fluctuate over the course of the program, but the rate of first-cycle approvals during the first month of the new user fee program is more than double the rate during the last year of the old iteration.