Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) are Regulatory submission documents which are required to be submitted to the Food and Drugs Administration (FDA) while filing a New Drug Application (NDA). The purpose of these documents is to report the outcomes of one or more clinical trials. With ISS and ISE, a single database is formed by pooling the results of all the clinical trials. This pool of database is much larger than those of individual studies, hence, it is easier to detect significant statistical differences in the treatment groups.

Elements of An ISS

  • Assessment of summaries and statistical analysis of safety data collected from various clinical studies
  • Evaluation of adverse event effects in various subgroups of the variable patient base
  • Impact of concomitant medications’ safety and efficacy
  • Assurance of the appropriate dosage of the drugs
  • Assurance of long term effect of the product, in case of chronic conditions
  • Identification of the effects of test products when used with other medications
  • Assurance that the results of the data support the benefits of the drug and overweighs the risks

Elements of An ISE

  • Assessment of collective summaries and statistical analysis of efficacy data collected from various clinical studies
  • Evaluation of adverse event effects in various subgroups of the variable patient base
  • Impact of concomitant medications’ safety and efficacy
  • Effectiveness of drug in case of chronic condition and assessment of its long-term effect
  • Evaluation of product for evidence of therapeutically active metabolite to contribute to the safety and efficacy of the product
  • Assurance that the results of the data support the benefits of the drug and overweighs the risks

The ISS and ISE are not just summaries, but they are a critical assessment of the data integrated which is derived from clinical studies. Compiling them is important to ensure the safety and efficacy of the intended product. Are you looking for assistance in authoring compliant ISS and ISE for your NDAs? Reach out to Freyr at sales@freyrsolutions.com.