Issue Date: November 22, 2016
Issued by: Center for Drug Evaluation and Research
Topic(s): User Fees, Generic Drugs
Status: Final
Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments: Guidance for Industry
This guidance provides answers to anticipated user-fee questions from generic drug industry participants regarding the Generic Drug User Fee Amendments of 2012 (Public Law 112-144, Title III), commonly referred to as GDUFA.2 The questions and answers (Q&A) format is intended to promote transparency and facilitate compliance. The first version of this document was issued pursuant to 21 CFR 10.115 and was made available on FDA’s website on August 22, 2012. In response to comments received in the docket and to address additional questions that have arisen since the beginning of GDUFA, FDA issued Revision 1 of the draft guidance on September 10, 2013.
Download the Guidance Document
