Today, the FDA issued Revision 1 to the above-referenced guidance. According to the Federal Register notice announcing the availability of the revision, “[T]he draft guidance announced in this notice revises and replaces the draft guidance for industry on ‘Assessing User Fees under the Generic Drug User Fee Amendments of 2017.’ This draft guidance addresses changes in user fee assessments from GDUFA I, user fees incurred by industry under GDUFA II, payment procedures, reconsideration and appeals, and other additional information to assist industry in complying with GDUFA II. Clarifying language was added to the revised draft guidance based on the public comments submitted for the draft guidance.”
The revised guidance can be found here and the FR notice can be found here. The original guidance issued in October 2017 can be found here. Happy reading and Happy Halloween! Be sure you know “witch” guidance you are reading because we don’t want to give you a scare, pumpkin!