Name
Qualitative Analysis of Inquiries Received by FDA Regarding Conduct of Clinical Trials during the Covid-19 Public Health Emergency
Speakers
Content Presented on Behalf of
USPHS/USSG
Services/Agencies represented
US Public Health Service/Health Human Services/Indian Health Service (USPHS/HHS/IHS)
Session Type
Breakout
Date
Wednesday, March 5, 2025
Start Time
3:15 PM
End Time
4:15 PM
Room#/Location
Woodrow Wilson D
Focus Areas/Topics
Policy/Management/Administrative
Learning Outcomes
1. Understand the role of the U.S. FDA during a PHE.
2. Learn about the experience of the FDA in establishing a dedicated mailbox and publishing guidance to address concerns about conducting clinical trials during the COVID-19 PHE.
3. Understand common themes and gain a better understanding of the clinical trial community’s interest and concerns during the COVID-19 pandemic.
4. Gain insights on future considerations for the post-PHE period based on the insights gained from analyzing the mailbox inquiries and the FDA’s experience in managing clinical trial-related communications during the PHE.
2. Learn about the experience of the FDA in establishing a dedicated mailbox and publishing guidance to address concerns about conducting clinical trials during the COVID-19 PHE.
3. Understand common themes and gain a better understanding of the clinical trial community’s interest and concerns during the COVID-19 pandemic.
4. Gain insights on future considerations for the post-PHE period based on the insights gained from analyzing the mailbox inquiries and the FDA’s experience in managing clinical trial-related communications during the PHE.
CE/CME Session
CE/CME Session
Session Currently Live