Back to Agenda
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 Tony Roman, MPharm
Head Regulatory Policy Emerging Markets LATAM
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)
Panelists
Peter P. Stein, MD
FDA, United States
Director, Office of New Drugs, CDER
Panelist
Celia M. Witten, MD, PhD
FDA, United States
Deputy Director, Office of the Center Director, CBER
Panelist
Melissa Torres, MS
FDA, United States
Associate Director for International Affairs, CDRH
Have an account?