FDA Safety Report Type Flag Requirement for FAERS Submissions February 19, 2021

Meeting

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• Date: February 19, 2021
• Time: 1:00 PM - 2:00 PM ET

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Slides

FDA will introduce the FAERS FDA Safety Report Type Flag and communicate how to prepare for this new requirement.

TOPICS

• Discuss and define the FDA Safety Report Type Flag
• Highlight benefits associated with the requirement
• Communicate implementation considerations

AUDIENCE

Members of the pharmaceutical industry responsible for the submission of adverse event reports to the FDA.

FDA SPEAKERS

Suranjan De, MS, MBA
Deputy Director
Regulatory Science Staff (RSS)
Office of Surveillance and Epidemiology (OSE)
CDER | FDA

Nik Rementelas
Project Manager
Office of Business Informatics (OBI)
Office of Strategic Programs (OSP)
CDER | FDA

FDA RESOURCES – WEBTEAM PLS HYPERLINK

• FDA Webpage: FDA Adverse Event Reporting System (FAERS) Electronic Submissions 
• Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments Technical Specifications Document