Webcast | Virtual

Event Title

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

April 15, 2026

Date:: April 15, 2026
Time:: 1:00 p.m. - 2:30 p.m. ET

Visit CDER Small Business and Industry Assistance (SBIA) Homepage

About this Event (Hosted by CDER SBIA)

Join the Small Business and Industry Assistance (SBIA) program for an informative webinar on the guidance, Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers. Expanded access is a pathway for patients with serious or immediately life-threatening diseases or conditions to gain access to investigational drugs for treatment outside of clinical trials when no comparable or satisfactory alternative treatment options are available.

The primary goal of this event is to provide attendees with a comprehensive understanding of this pathway, including the regulatory requirements and FDA’s recommendations. The session will detail the three categories of Expanded Access (EA): individual patient, intermediate-size population, and treatment INDs and protocols, and will increase participants’ understanding of the criteria, submission requirements, and responsibilities of all parties involved.

Through presentation and panel discussion the webinar will address frequently asked questions about the program, share useful resources including forms, templates, websites, and clarify common misconceptions about the program. Attendees will be able to leverage the knowledge and resources from this webinar to facilitate safe, compliant, and timely access to investigational treatments for patients in need.

Intended Audience

Drug sponsors and regulatory affairs professionals working on investigational drug development programs who submit INDs for expanded access requests (Note: This guidance does not apply to generic drugs (ANDAs) as it specifically covers investigational drugs under IND regulations).
Researchers working on clinical development of investigational drugs and biologics for serious or immediately life-threatening diseases or conditions
Consultants focused on expanded access program development, compassionate use strategies, IND regulatory submissions, and helping pharmaceutical companies establish expanded access policies required under the 21st Century Cures Act and FDARA
Clinical research coordinators managing expanded access INDs and protocols
Healthcare professionals specializing in treating patients with serious or life-threatening conditions who may submit individual patient expanded access INDs or serve as sponsor-investigators for expanded access requests
Foreign regulators interested in understanding FDA's expanded access framework for investigational drugs
Patients and patient advocacy groups representing individuals with serious or immediately life-threatening diseases or conditions who lack satisfactory therapeutic alternatives. This includes patient advocates seeking to understand how to navigate FDA’s expanded access process.
Institutional Review Boards (IRBs) and IRB administrators responsible for reviewing and approving expanded access INDs and protocols

Topics Covered

Framework for FDA’s Expanded Access (EA) program, including new statutory requirements added by the 21^st Century Cures Act (2016) and FDA Reauthorization Act (FDARA) (2017)
Process for submission of expanded access requests to FDA
Reporting requirements for EA requests
FDA’s process for review of EA requests
Available tools and resources related to the EA program

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

Presenter

Atasi Poddar, PhD
Health Science Policy Analyst
Division of Medical Policy Development | Office of Medical Policy | CDER | FDA

Panel Discussion

Moderator

Mathilda Fienkeng, PharmD, MS
Captain | United States Public Health Service (USPHS)
Director
Division of Medical Policy Development (DMPD) | Office of Medical Policy (OMP)
Center For Drug Evaluation and Research (CDER) | FDA

Panelists

Mitchell Chan, PharmD, MSDA, BCPS
Commander | USPHS
Clinical Analyst, Team Lead
Project Facilitate
Oncology Center of Excellence | FDA

David Faranda, JD
Senior Regulatory Counsel
Division of Regulatory Policy IV | Office of Regulatory Policy | CDER | FDA

Atasi Poddar, PhD
Health Science Policy Analyst
DMPD | OMP | CDER | FDA

Xiaoqiu Tang, MD, MS
Consumer Safety Officer
Office of Regulatory Operations | CBER | FDA

Continuing Education (CE)

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been pre-approved by:

RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.