Can I read GDUFA Guidance for PAS Submissions on EtoBox?

GDUFA Guidance for PAS Submissions by Sreekanth Ch is a document available to read on EtoBox.

What is GDUFA Guidance for PAS Submissions about?

This draft guidance provides information to generic drug sponsors on submitting prior approval supplements (PAS) under the Generic Drug User Fee Amendments (GDUFA). It outlines GDUFA performance metrics for reviewing PAS submissions within 6 or 10 months depending on whether an inspection is needed. The guidance describes procedures that can impact the review timeline, such as refusing submissions, amendments, inspections, grouped supplements, and incorrect reporting categories. It is intended to help spons

Author

Sreekanth Ch

Language

EN