FDA Releases Personalized Medicine Report

Next-generation sequencing (NGS)-based tests, complex laboratory-developed tests (LDTs), and companion diagnostics are all challenging the conventional regulatory process at the U.S. Food and Drug Administration (FDA). In an October report, “Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development,” the agency details how it is responding to and anticipating challenges related to review of personalized medicine (PM) products and the measures it plans to take to ensure the regulatory processes are properly suited to address these rapid innovations. The FDA says the era of PM is definitely here and cites internal evidence that of the new drugs approved since 2011, approximately one-third included some form of genetic or other biomarker data in the submission to characterize the drug’s efficacy, safety, or pharmacokinetics. Additionally, more than 100 approved drugs contain labeling information on genomic biomarkers. “The FDA has worked to bridge developments in genomics and other relevant sciences to clinical practice by advancing the tools necessary for evaluating targeted therapeutics and bringing them to market more efficiently, collaborating in key research, defining and streamlining regulatory pathways and policies, and applying new knowledge in product reviews,” the report says. Core to the FDA’s responsibilities is […]