FDA updates guidance on classifying ANDA amendments for GDUFA III
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.
One major update to the guidance is the addition of new text limiting the circumstances for when FDA can consider a deficiency a major deficiency in Appendix A. The text states that FDA “will attempt to resolve possible deficiencies identified during the assessment cycle through the information requests (IRs) and discipline review letters (DRLs) prior to sending them in a complete response letter (CRL) and that unresolved deifncies will result in a major or minor.”
This change “addressed a significant number of public comments” from the docket, said Andrew McIntosh, a project manager for the Office of Generic Drugs in the Center for Drug Evaluation and Research explained the background leading to these changes at a 10 September webinar sponsored by the Small Business and Industry Assistance (SBIA).
Teva had stated in its comments that it is “critical that FDA classify deficiencies as major only when truly warranted … when the deficiency cannot be resolved through another mechanism and the additional review time is necessary to assure the safety and efficacy of the drug. It is our experience that some of the deficiencies currently listed in Appendix A can reasonably be considered minor.”
Other changes include updated examples of major amendments, minor amendments, and unsolicited amendments.
The guidance also offers updated examples of major amendments, priority assessments and a minor PAS amendment. These different types of amendments are subject to different review timetables under GDUFA.
The guidance also updates the list of potential major deficiencies in Appendix A on the drug substance, drug product, process, microbiology, and bioequivalence. Appendix B has been removed which defines an amendment is classified as major pr itor.
Mcintosh told the webinar that the Office of Generic Drugs is rolling out a discipline specific training for each OGD or Office of Pharmaceutical Quality (OPQ) discipline review involved with the assessment process said that in accordance with the GDUFA 3 commitment and to ensure consistency in the ANDA amendment classification.
Comments may be submitted to this guidance at any time.
Final guidance
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