FDA Issues Final Guidance for ANDA/PAS Amendments Under GDUFA II

The FDA released final guidance spelling out its review goals for amendments to abbreviated new drug applications and prior approval supplements under GDUFA II.

Under the new system, the FDA will review and act on 90 percent of standard major ANDA amendments within eight months of submission if the agency does not require a preapproval inspection. In cases where an inspection is necessary, the timeline will be 10 months.

For priority major ANDA amendments, the agency will review and respond to 90 percent of such amendments within six months in cases where preapproval inspection is not required, and act on 90 percent of standard and priority 90 percent minor ANDA amendments within three months of submission.