This one-day hybrid (virtual and in person) workshop will initiate a discussion on expanding epinephrine accessibility and use, including in community settings, to reduce anaphylaxis-related morbidity and mortality. This public workshop is convened by FDA and the Duke-Margolis Institute for Health Policy.

The format of the workshop will consist of a series of presentations, panel discussions, and open discussion. Key topics to be discussed are:

Allergic diseases, anaphylaxis, and treatment of anaphylaxis in the community setting
Regulatory pathways for epinephrine products, including considerations for prescription and nonprescription development
Current accessibility to epinephrine for treating anaphylaxis
Opportunity to enhance access to and use of epinephrine

Learn more about the workshop here

FDA has opened docket FDA-2025-N-2976 for public comment and instructions for submitting comments are included in the Federal Register Notice. Comments will be accepted until January 16, 2026, and untimely filed comments will not be considered. Timely comments will be publicly viewable in the docket at https://www.regulations.gov except for those submitted as “Confidential Submissions”.

Participating in the Public Workshop:

Registration is free for both in-person and virtual attendance. To register for the public workshop please visit the following website https://duke.is/EpiAccess. If you need special accommodations due to a disability, please contact margolisevents@duke.edu no later than December 2, 2025, 11:59 p.m. EST.

During online registration you may indicate if you wish to present during a public comment session.

Requests for Oral Presentations must be submitted by November 21, 2025.
Notification of participants for oral presentations will begin by December 1, 2025
If selected, presentation materials are due by December 11, 2025.