ANDA Review Times Will Not Come Down In Next Two Years, FDA Predicts
This article was originally published in The Pink Sheet Daily
Executive Summary
Estimates in President Obama’s budget request indicate the ANDA median review time will remain 42 months in FY 2015 and FY 2016, even though FDA also predicts a reduction in applications and an increase in approval actions.
You may also be interested in...
ANDA Approval Times Get Optimistic Estimate In Budget Request
US FDA has historically overestimated generic review performance in budget requests, but recently underestimated the number of ANDAs it expects to approve.
ANDA Approval Times Get Optimistic Estimate In Budget Request
US FDA has historically overestimated generic review performance in budget requests, but recently underestimated the number of ANDAs it expects to approve.
Parallel Scientific Advice: Is The EMA User Fee Impacting Interest?
EMA charges participants to receive scientific advice through the fledgling program, unlike the US FDA, which may not fit the budgets of some complex generic sponsors. At the same time, sponsors also may simply not be aware the program exists yet.