Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers

This webinar provided a comprehensive understanding of the expanded access pathway for patients with serious or immediately life-threatening diseases or conditions to gain access to investigational drugs outside of clinical trials when no comparable treatment options are available. The presentation detailed the three categories of Expanded Access (EA): individual patient, intermediate-size population, and treatment INDs and protocols. Regulatory requirements, FDA recommendations, criteria, submission requirements, and responsibilities of all parties involved were explained to support effective implementation of this critical treatment pathway. Timestamps 00:25 – Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers 38:08 – Discussion Panel 01:07:00 – Q&A Panel 01:24:25 – Webinar Closeout Speaker: Atasi Poddar, PhD Health Science Policy Analyst Division of Medical Policy Development (DMPD) Office of Medical Policy (OMP) Center for Drug Evaluation and Research (CDER) | FDA Discussion Panel: Moderator Mathilda Fienkeng, PharmD, MS Captain United States Public Health Service (USPHS) Director DMPD | OMP | CDER | FDA Mitchell Chan, PharmD, MSDA, BCPS Commander | USPHS Clinical Analyst, Team Lead Project Facilitate Oncology Center of Excellence (OCE) | FDA David Faranda, JD Senior Regulatory Counsel Division of Regulatory Policy IV (DRPIV) Office of Regulatory Policy (ORA) CDER | FDA Xiaoqiu Tang, MD, MS Consumer Safety Officer Office of Regulatory Operations (ORO) Center for Biologics Evaluation and Research CBER | FDA And Atasi Poddar Learn more at: https://www.fda.gov/drugs/news-events... ----------------------- FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2024 Playlist -    • 2024 CDER Small Business and Industry Assi...   SBIA 2025 Playlist -    • 2025 CDER Small Business and Industry Assi...   SBIA LinkedIn -   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - [email protected] Phone - (301) 796-6707 I (866) 405-5367