FDA Releases Final Guidance on Abbreviated New Drug Application Submissions Under the Generic Drug User Fee Act

Summary

The Food and Drug Administration (FDA) has released a final guidance document outlining the process for submitting amendments to abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) under the Generic Drug User Fee Act (GDUFA). The guidance clarifies how review goals established as part of the GDUFA II apply to these amendments, and explains how FDA will review amendments submitted prior to October 1, 2017.