Let's Get Real – ANDA Approval Likely Takes More Than Two Years, US FDA Says
Office of Generic Drugs Director Kathleen Uhl calls a two-cycle approval timeline a realistic expectation for ANDA approval, but would not say that most ANDAs will fall into the paradigm.
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Three-to-five year timeline needed to develop algorithms does not engender confidence that new version of formula, which historically pushed user fee rates higher, will be ready before PDUFA VII begins.
ANDA Median Approval Times Still Rising, But What Does It Mean?
First quarterly report of median US generic drug times shows longer time to approval than previous estimates, but that may not tell stakeholders much.
GDUFA II Reviews Start Strong With High First-Cycle Approval Rate
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.