FDA Releases Guidance on GDUFA Self-Identification

September 22, 2016

The agency published the guidance to help generic-drug facilities comply with the GDUFA self-identification requirement.

The Generic Drug User Fee Amendments of 2012 (GDUFA) requires generic-drug facilities to annually submit identification information to FDA. On Sept. 22, 2016, FDA released guidance to assist companies with complying with the self-identification requirement.

Self-identification is required to determine the facilities required to pay user fees and to promote global supply chain transparency. The guidance discusses which types of generic facilities, sites, and organizations are required to self-identify; what information is requested; what technical standards are to be used for electronically submitting the requested information; and the penalty for failing to self-identify.

Source: FDA