integrated summary of safety
- Guideline or reference source
- FDAIS Integrated Summaries of Effictiveness and Safety: Location Within the Common Technical Document
- Definition
- The ISS is not a summary but rather a detailed integrated analysis of all relevant data from clinical study reports that belong in Module 5.2. The FDA considers the ISE and ISS critical components of the clinical efficacy and safety portions of a marketing or licensing application.
- Abbreviation for
- ISS
- Related Term
- integrate summary of efficacy
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