FDA Will Soon Begin Alerting Generics Firms To Facility Compliance Status

26 Jul 2017

US FDA's GDUFA II commitment to alert generics firms within 90 days regarding inspection results will put additional pressure on Form 483 responses, possibly starting later this year.

In return for learning more quickly whether quality issues could derail approvals, generics firms will face greater pressure to respond quickly to Form 483 inspectional findings, an FDA compliance official said last month.

The new pressure could begin later this year.