The FDA has released a new draft guidance for sponsors and sponsor investigators entitled “Safety Reporting Requirements and Safety Assessment for Investigational New Drug (IND) Application and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 The draft guidance document includes: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On the Federal Register’s notice page for this document, you will find a summary of the draft guidance along with supplementary information and a tool for submitting a formal comment. The draft guidance is open for comments until September 27, 2021.
