GDUFA Self-Identification Reporting Period Now OPEN for FY 2017

The Generic Drug User Fee Amendments of 2012 (GDUFA) Fiscal year 2017 self-identification reporting period is open from May 1st to June 1^st, 2016. Self-Identification is an annual requirement, whether or not company information has changed.

GDUFA requires that human generic drug facilities and certain sites and organizations identified in a generic drug submission provide identification information annually to FDA.   This information will assist in constructing an accurate inventory of facilities, sites and organizations involved in the manufacture of generic drugs, setting annual facility fee amounts, and targeting inspections. You may find additional information on our GDUFA webpage.

We also offer the following web-based learning courses to help you understand GDUFA:

• Overview of the Generic Drug User Fee Amendments of 2012  
• Generic Drug User Fee Amendments Self-Identification Structured Product Labeling (SPL) SubmissionPart 1 and Part 2