ANDA Complete Responses Spike In FY 2018, But Why?
In the first quarter of FY 2018, the agency issued over 800 CRs for generic drug applications, more than half the total it issued in all of FY 2017.
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ANDAs By The Numbers: Metrics Look Good – But Review Processes Need Attention Too
US FDA is approving generics at record pace, providing important statistics to support efforts by Commissioner Gottlieb to position the agency as part of the solution to concerns about high drug prices; new guidance for industry and FDA reviewers, however, suggests there is still a need for more rigor in preparing and assessing submissions.
In Switching Generic 'Reviews' To 'Assessments' Is US FDA Changing More Than Just A Word?
MaPP revision may be just a better description of ANDA evaluations – or indicative of a broad culture change, experts tell the Pink Sheet.
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.