UPDATED: FDA Requesting Comments on Biomarker List

U.S. FDA News

FDA has announced the opening of a docket (FDA-2016-N-2610) for interested parties (academic researchers, regulated industries, consortia, patient groups, etc.) to submit suggestions, recommendations and comments on a 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.

According to FDA, the purpose of the list will be to provide examples of biomarkers that were accepted and used as endpoints in clinical trials for drug and biologic approvals from October 2007 to December 2015.  FDA is specifically looking for comments regarding (1) areas of improvement for communicating and disseminating information about biomarkers and their utility as drug development tools; and (2) the best approach for updating the biomarkers outcomes list, including any modifications of the list, in the future.  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.

UPDATE (09/23/2016):  FDA is publishing a correction to its prior announcement to add a link to its biomarker list, which was left out of the original notice and can be found here. The post above has been modified to reflect this correction.

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