The US Food and Drug Administration (FDA) on Thursday issued updated guidance on the classification of amendments to abbreviated new drug applications (ANDAs) or prior approval supplements (PASs) that reflects the recent reauthorization of the Generic Drug User Fee Amendments (GDUFA III).
This guidance revises a previous version issued in July 2018 and includes some changes to reflect the recent reauthorization of GDUFA. It also addresses comments received in response to a 2022 public docket soliciting feedback on the guidance; FDA received 8 comments from generic drugmakers and the generic drug lobby group the Association for Accessible Medicine. In its request for comments, FDA asked respondents to address Appendix A of the guidance listing the different types of potential major deficiencies.
