Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine

This hybrid public workshop will initiate a discussion on expanding epinephrine accessibility and use, including in community settings, to reduce anaphylaxis-related morbidity and mortality. 

Key topics attendees will hear more about: 

• 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 
• Opportunities to enhance access to and use of epinephrine  

Ahead of the workshop, the FDA has created a public docket that will inform the planning of the event and future work related to epinephrine access. Responses can be submitted here and the docket closes on January 16, 2026. This event will also feature a public comment session where attendees may share feedback through oral presentations. During online registration individuals may indicate if they wish to present during the public comment session. All requests to make oral presentations must be received by November 21, 2025.

This event is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD008451 totaling $1,399,999 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.