Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers April 15, 2026

https://www.fda.gov/drugs/news-events-human-drugs/expanded-access-investigational-drugs-treatment-use-questions-and-answers-04152026?utm_medium=email&utm_source=govdelivery 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.