Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies June 30, 2021

Webcast | Virtual

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• Date: June 30, 2021

 

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Safety Reporting Requirements and Safety Assessment for IND and BA BE Studies (PDF - 621KB)

FDA is providing background on investigational new drug (IND) safety reporting and will introduce listeners to the new guidance Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies.  Learn about new content covered in this guidance. 

Topics

• History and overview of 2010 IND Safety Rule and Related Safety Reporting Guidance
• Reporting & Aggregate Analyses: Considerations & Methods
• Pooling Data Across Studies
• Aggregate Analyses: Reporting Thresholds
• Entity(ies) Who Should Review Safety Information
• Unblinding of Safety Data and Implications
• Safety Surveillance Plan
• IND Safety Reporting for Marketed Drugs and Active Control
• Electronic reporting using ICH E2B standards

INTENDED AUDIENCE

• Sponsors of IND or BA/BE clinical trial studies
• Clinical investigators of IND or BA/BE clinical trial studies
• Contract Research Organizations working for Sponsors of IND or BA/BE clinical trial studies
• Institutional Review Boards for IND or BA/BE clinical trial studies

FDA PRESENTER

Paul M. Gouge, J.D.
Regulatory Counsel
Division of Clinical Trial Quality (DCTQ) | Office of Medical Policy Initiatives | CDER | FDA

FDA RESOURCES

• FDA IND Safety Reporting Website 
• FDA Draft Guidance: Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies

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Event Materials

Title	File Type/Size
Safety Reporting Requirements and Safety Assessment for IND and BA BE Studies	pdf (620.81 KB)