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Session 4 Follow Up: Transitioning EUA to Full Approvals: Regulatory Perspectives and Lessons for Future Pandemics
Session Chair(s)
Cammilla Horta Gomes, MA, MPHARM
Latam Regulatory Policy Lead , Roche, Brazil
Maria Antonieta Roman
Head Regulatory Policy LaCan, Novartis, Mexico
Some regulatory agencies have established Emergency Use Authorization (EUA) to ensure that potentially lifesaving medical products could be available to people in medical need when there is not an approved and available alternative after demonstrating product effectiveness and that “potential benefits outweigh the known and potential risks”. Products that were granted EUA are expected to transition to full approvals, offering advantages for the public and pharmaceutical companies. This short session will highlight the FDA experience with accelerated timelines and need for risk-based decision-making during the COVID-19 pandemic, and present lessons that should be considered by regulators in Latin America and the Caribbean in preparation for future health emergencies.
Learning Objective : At the conclusion of this session, participants should be able to:- Recognize the differences between an emergency use authorization and a full approval
- Describe the process for authorizing EUAs and the transition to full approval
- Assess additional perspectives on EUAs
Speaker(s)
Peter Stein, MD
Consultant, Peter Stein Consulting, LLC, United States
Celia M. Witten, MD, PHD
Deputy Director, Office of the Center Director, CBER, FDA, United States
Melissa Torres, MS
Associate Director for International Affairs, CDRH, FDA, United States
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