The RAPS store will be under maintenance Saturday, 17 April between 5 AM and 12 PM EST. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.

  • Feature ArticlesFeature Articles

    Minimal Residual Disease as a Surrogate Endpoint for Product Development for Multiple Myeloma: Comparing FDA and EMA Guidances

    This article discusses the need to update regulatory science to include the use of Minimal Residual Disease (MRD) as a specific measure of tumor burden for multiple myeloma at levels undetectable through conventional laboratory techniques. The authors suggest MRD can potentially be used as a clinical and regulatory endpoint to evaluate a drug’s effect both on patients’ risk of future relapse risk and subsequent treatment survival outcomes, thus serving as a surrogate endpo...