FDA publishes Expanded Access Q&A webinar materials
- Indication
- guidance — investigational drug access pathway
FDA's CDER Small Business and Industry Assistance (SBIA) program has published the materials from its April 15, 2026 webinar on the Expanded Access pathway for investigational drugs. The session covers the three EA categories (individual patient, intermediate-size population, treatment INDs and protocols) along with submission requirements, sponsor responsibilities, and common misconceptions.
Read original at fda.gov ↗From the source
Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers
Date: April 15, 2026 Time: 1:00 p.m. – 2:30 p.m. ET Hosted by: CDER Small Business and Industry Assistance (SBIA)
About this Event:
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 • 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.
Reproduced from FDA Drugs (Whats New) · view original · public domain or open-licensed government work