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

The primary goal of this event was to provide attendees with a comprehensive understanding of this pathway, including the regulatory requirements and FDA’s recommendations. The session detailed the three categories of Expanded Access (EA): individual patient, intermediate-size population, and treatment INDs and protocols, and increased participants’ understanding of the criteria, submission requirements, and responsibilities of all parties involved. Through presentation and panel discussion the webinar addressed frequently asked questions about the program, shared useful resources including forms, templates, websites, and clarified common misconceptions about the program. Attendees were able to leverage the knowledge and resources from this webinar to facilitate safe, compliant, and timely access to investigational treatments for patients in need. 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