Back to: FDA Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine
About
This session will cover the regulatory pathway for approval of epinephrine products for treatment of anaphylaxis in the community setting and the risk-benefit considerations for epinephrine use as a prescription or nonprescription drug. Discussion will include the available dosage forms, delivery devices, use in adults versus pediatrics, data requirements to demonstrate that a drug is appropriate for nonprescription use, including assessments of consumer behavior as well as the capacity for consumers to self-diagnose allergies associated with anaphylaxis and self-diagnose anaphylaxis.
Moderator:
Thomas Roades
Duke-Margolis Institute for Health Policy
Presenters:
Karen Murry
U.S. Food and Drug Administration
Miya Paterniti
U.S. Food and Drug Administration
Panelists:
Carla Davis
Howard University
Paul Greenberger
Northwestern University
Sheila Heitzig
American Academy of Allergy, Asthma, and Immunology
Alice Hoyt
Code Ana
Kelly Stone
U.S. Food and Drug Administration