This guidance provides answers to anticipated questions from generic drug industry participants regarding the implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA) (Public Law 112-144, Title III), commonly referred to as GDUFA. 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.
FDA is revising this draft guidance. The revision clarifies some of the questions and answers included in the first version and adds several new questions and answers that have arisen since the launch of the program, including questions FDA received following issuance of the first draft of the guidance.