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Webcast

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


Date:
June 30, 2021
Time:
12:00 PM - 1:00 PM ET

 

Visit CDER Small Business and Industry Assistance

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


Event Materials

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