'Bridging' Of Generic Review Goal Dates Makes Progress At US FDA
Executive Summary
Assigning official goal dates to ANDAs that hadn't been included in GDUFA began in mid-October and already has lead to approvals.
You may also be interested in...
There's The Bolus! ANDA Sponsors Race To Avoid User Fee Spike
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.
GDUFA II Will Include Small Business Relief, Priority ANDA Reviews
Generics industry and FDA have resolved remaining issues regarding financing of user fee program.
FDA Meets ANDA Backlog Goal Early, Still Doesn't Feel Out Of Woods
Office of Generic Drugs reviewed more than 90% of official GDUFA backlog of pending applications, but many still will require more work.