Katrina’s Blog™

Per the requirements in the 21st Century Cures Act, the FDA has published this month the first ever “Table of Surrogate Endpoints That Were the Basis of Drug Approval or Licensure”. Surrogate endpoints (SEs, not to be confused with Substantial Equivalence for medical...

- is a good example of the requirements for qualification under the Biomarker Qualification ProgramThere is considerable public interest in using biomarkers (measurements of substances present in the body or physical health parameters such as blood pressure or changes...

The FDA has posted a Request for Comments to better understand how to regulate software developed by drug sponsors for use with their prescription drugs (Docket No. FDA-2018-N-3017). The request notes that sponsors who have been developing software apps to market with...

In early November, the FDA announced they were releasing the open source code and technical information for their MyStudies app. This app was developed and piloted by the FDA as a way for patients enrolled in a clinical trial to enter their own health data which would...

In an earlier post I noted that pathology experts believe next generation sequencing will be required to bring minimal residual disease (MRD) into focus as a more valuable endpoint for clinical trials of leukemia treatments. I’ve reviewed the technique, which starts...