Back to: FDA Generic Drugs Forum 2025
Presenter
Joe Shin, PharmD
Lead Regulatory Health Project Manager
Division of Project Management (DPM)
Office of Regulatory Operations (ORO)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Dr. Joe Shin has been with the FDA since 2014, serving as a Regulatory Project Manager prior to his current position as Lead Regulatory Health Project Manager in the Division of Project Management (DPM), Office of Regulatory Operations (ORO) within the Office of Generic Drugs (OGD). He leads a team of RPMs providing guidance and support as they manage the regulatory review process of Abbreviated New Drug Applications. He also serves as DPM’s subject matter expert on Requests for Reconsideration providing expertise and training to numerous offices in OGD. He received his Doctor of Pharmacy degree from Howard University in 2008.
Abstract
In his presentation Dr. Joe Shin, Regulatory Health Project Manager at FDA, outlines the purpose, process, and key best practices for submitting a Request for Reconsideration (RFR) under GDUFA. He explains that RFRs are meant for applicants seeking reconsideration of specific FDA regulatory actions related to ANDAs that hold scientific significance. Dr. Shin emphasizes the importance of submitting timely, stand-alone RFRs that adhere strictly to the October 2024 final guidance—particularly its content and format requirements—and cautions against including new information not originally considered by FDA. He highlights common pitfalls that lead to RFRs being deemed not acceptable and offers practical advice to increase acceptance rates and reduce unnecessary administrative burden. His goal is to help industry stakeholders navigate the RFR process effectively and ensure more first-time acceptances for FDA evaluation.