Back to: FDA Generic Drugs Forum 2025
Presenter
Yi Zhang, PhD
Associate Director
Division of Bioequivalence III (DBIII)
Office of Bioequivalence (OB)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Dr. Yi Zhang is the Associate Director for Division of Bioequivalence III in the Office of Bioequivalence, Office of Generic Drug. Dr. Zhang joined Office of Bioequivalence in 2014, and throughout his tenure, Dr. Zhang has served as a primary, secondary, and tertiary assessor to conduct critical evaluation of bioequivalence studies in abbreviated new drug applications (ANDAs), Control Correspondences (CCs), Protocols, and various other regulatory submissions for generic drug products, where he works collaboratively to address complex issues identified during bioequivalence assessments. Dr. Zhang is currently involved in several working groups and research projects at divisional and office levels to support scientific and regulatory-based decisions making for the review of generic products.
Abstract
At the 2025 Generic Drugs Forum, Yi Zhang from the FDA’s Office of Bioequivalence (Division 3) presents an overview of the Request for Reconsideration (RFR) process under GDUFA III from a bioequivalence (BE) perspective. The talk outlines FDA’s procedures for accepting, reviewing, and responding to RFRs, emphasizing that new information cannot be introduced through an RFR. Zhang highlights that most RFRs reviewed by OB involve reclassification requests from major to minor deficiencies, with about one-third granted. Case studies illustrate key considerations, including FDA’s discretion in classifying amendments and the importance of submitting substantial new data as a CRL amendment rather than through an RFR. The presentation reinforces that RFRs are a tool for resolving scientific and regulatory issues but are limited to responses to formal regulatory actions, not advisory letters like DRLs.