'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.

FDA entrance sign 2016

The US FDA recently placed many additional ANDAs on a review clock and has already approved some of them as part of a program to account for all GDUFA I hold-overs.

These applications are some of the older submissions in the generic drug user fee program – received before the agency...

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