'Bridging' Of Generic Review Goal Dates Makes Progress At US FDA
Assigning official goal dates to ANDAs that hadn't been included in GDUFA began in mid-October and already has lead to approvals.
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In a year defined by application surges, more than 200 ANDAs were submitted in September, the last month of fiscal year 2017, likely to avoid paying a much higher application fee instituted Oct. 1.
Generics industry and FDA have resolved remaining issues regarding financing of user fee program.
Office of Generic Drugs reviewed more than 90% of official GDUFA backlog of pending applications, but many still will require more work.