ANDA Median Approval Times Still Rising, But What Does It Mean?

First quarterly report of median US generic drug times shows longer time to approval than previous estimates, but that may not tell stakeholders much.

The US FDA is reporting median and mean ANDA approval times quarterly as part of GDUFA II, but the data may not offer much help for stakeholders tracking agency performance.

The report suggests ANDA approval times continue to slow, despite more than five years working under the generic drug user...