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New Draft Guidance for Investigational New Drug Application and Bioavailability/Bioequivalence Studies

The FDA has released a new draft guidance for sponsors and sponsor investigators entitled “Safety Reporting Requirements and Safety Assessment for Investigational New Drug (IND) Application and Bioavailability/Bioequivalence Studies.” The draft guidance document includes:

  • Definitions of adverse event, adverse reaction, suspected adverse reaction, unexpected, serious, and life-threatening.
  • An overview of IND application safety reporting requirements.
  • A systematic approach for review of safety information.
  • Considerations for aggregate data analysis for IND safety reporting.
  • Other safety reporting issues.
  • Details on submitting and IND safety report.
  • Safety reporting requirements for bioavailability and bioequivalence studies.

 

On the Federal Register’s notice page for this document, you will find a summary of the draft guidance along with supplementary information and a tool for submitting a formal comment. The draft guidance is open for comments until September 27, 2021.

Federal Register Notice | Official Document