This post was written by Erin Janssen.
On August 27, 2012, FDA issued draft guidance documents for industry entitled “Self-Identification of Generic Drug Facilities, Sites, and Organizations” and “Generic Drug User Fee Amendments of 2012: Questions and Answers.” The Generic Drug User Fee Amendments of 2012 (GDUFA) requires that generic drug facilities, sites, and organizations around the world provide identification information annually to FDA. The GDUFA also is designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry, and enable FDA to assess user fees to support enhancements to FDA’s generic drugs program. The first draft guidance document is intended to assist industry as it prepares to meet the law’s self identification requirement. It explains who is required to self-identify, what information must be requested, how the information should be submitted to FDA, and what the penalty is for failure to self-identify. The second guidance document answers common questions from the generic drug industry and other interested parties involved in the development and/or testing of generic drug products regarding the requirements and commitments of GDUFA. To be considered before FDA begins work on the final versions of these documents, comments should be submitted by October 26, 2012.