The TED Initiative is pleased to announce receipt of the first FDA Center for Devices and Radiologic Health (CDRH) Recognition of Research Importance Letter regarding TBI. This letter, under the signature of Jeffrey Shuren, MD, JD, Director of CDRH, demonstrates FDA’s acknowledgment and commitment to our field.

As part of the FDA’s ongoing effort to ensure patients and providers have timely and continued access to safe, effective, and high-quality medical devices, the FDA

The Food and Drug Administration (FDA), in co-sponsorship with the Foundation for the National Institutes of Health Biomarkers Consortium (FNIH BC), is announcing a public workshop entitled “Developing an Evidentiary Standards Framework for Safety Biomarkers Qualification Workshop.” The purpose of the workshop is to discuss the evidentiary standards needed to support biomarker qualification with a particular emphasis on drug safety markers.

This public workshop aims to examine potential biomarkers, discuss the challenges and solutions related to biomarker development methodologies, and establish strategies for data standardization, sharing and analysis of big data sets for Traumatic Brain Injury (TBI). By convening the relevant stakeholders, the goal is to obtain input on the scientific, clinical, patient and regulatory considerations associated with TBI biomarker development to improve diagnosis and clinical utility for TBI.