FDA to Issue Public Docket of Biomarkers Used in Drug Development

FDA plans to release a list of biomarkers and is soliciting public recommendations and comments to determine the usefulness of the list in drug development.

The list consists of examples of biomarkers used as outcomes to develop FDA-approved new molecular entities and new biological therapeutics, from October 2007 to December 2015.

Specifically, FDA is seeking comments regarding: improvements in communicating and disseminating information about biomarkers and their utility as drug development tools; and the best approach for updating the biomarkers outcomes list, including any modifications of the list, in the future.