FDA Open to Biomarker Comments

FDA has announced the opening of a docket for interested parties to submit suggestions, recommendations, and comments on a proposed list of biomarkers that were used as outcomes to develop FDA-approved new molecular entities and new biological therapeutics from October 2007 to December 2015. The submissions from interested parties will help FDA determine the utility of the list and may assist FDA in developing databases on biomarkers for drug development. The 60-day window for submitting comments will close on November 18, 2016. The submissions can be either public or confidential. Specifically, FDA welcomes comments regarding the following two areas: Areas of improvement for communicating and disseminating information about biomarkers and their utility as drug development tools. The best approach for updating the biomarkers outcomes list, including any modifications of the list, in the future. FDA Perspective of Biomarkers The agency has consistently described the importance of biomarkers. A biomarker is “a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or biological responses to a therapeutic intervention”. Illustrating their importance, the FDA’s Center for Drug Evaluation and Research (CDER) established the Biomarker Qualification Program to support its work with external stakeholders to develop biomarkers that aid in the drug development process. Through the FDA’s Biomarker ...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs