Dark, Then Dawn: ANDA Workload Approaching Steady State After 2014 Eruption

FDA Office of Generic Drugs' output is beginning to compete with, rather than be overwhelmed by, sponsors' input.

Steady state, here we come! It's not the most exciting rallying cry, but for FDA's Office of Generic Drugs, it's an important target, and one OGD seems to be approaching as it now frequently approves more applications than it receives in a given month.

After June 2014, when a record number of ANDAs were submitted, output from the Office of Generic Drugs began to...

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