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With Increasing New Drug INDs Projected, How Much More Workload Can US FDA Handle?

 
• By Derrick Gingery

Meanwhile, the biosimilars program is expecting essentially flat application numbers, but more manufacturing supplements and more development meetings, which likely is an indication of the sector’s flourishing in the US.

workload
While INDs are expected to increase in CDER and CBER, fewer efficacy and manufacturing supplements are expected to be submitted. • Source: Shutterstock

An explosion in drug review workload could be on the horizon, which may make a predicted near-term decline in areas related to approved products all that more appreciated by the US Food and Drug Administration.

The FDA’s Center for Drug Evaluation and Research in fiscal year 2023 is expected to have 10,389 acting commercial INDs, a nearly 15% increase from the total in FY 2021, according to the

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