The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
On April 15, 2013, the U.S. Food and Drug Administration published a Federal Register notice announcing the fiscal year (FY) 2014 reporting period (May 1, 2013 -- June 1, 2013) for self-identification of generic drug facilities, sites and organizations. Under GDUFA, human generic drug facilities, sites and organizations are required to submit, update, or reconfirm their identification information annually.
This notice specifies the FY 2014 reporting period from May 1, 2013 - June 1, 2013; the second year that self-identification is required. It summarizes the requirement and refers readers to additional information on FDA’s GDUFA web page (www.fda.gov/gdufa) including who is required to self-identify, the type of information required, the format for submission, and the penalty for failing to comply. The notice can be found at http://www.fda.gov/
Questions about GDUFA can be sent to AskGDUFA@fda.hhs.gov or (866)-405-5367.