ANDA Reviews Sometimes Miss GDUFA Goal Dates To Get Quicker Approval, But How Often?

Preliminary performance data suggests only a handful of applications receiving US FDA action by the end of FY 2018 actually missed their review goals.

FDAEntrance_1200x675 — Sponsors are interested to learn more about when the US FDA will miss a goal date in order to reach a faster ANDA approval or tentative approval. • Source: File photo

US Food and Drug Administration assessors apparently have worked past a user fee goal several times in order to reach a faster generic drug approval, which is good news for sponsors.

However, the agency is not willing to do much more at this point than acknowledge it is occurring, which likely...