For many years now the FDA has made submission of pharmacogenomic data voluntary for most types of applications (here’s the pharmacogenomic submission guidance and its companion document, both issued in 2005). This guidance is on CDER’s update publication schedule for 2019 and is still pending notification as of this post. Some feel this type of data should be required for all clinical trials (see this 2007 paper by a pair of scientists at St. Jude’s Children’s Research Hospital). I was interested in what type(s) of data have been submitted voluntarily, so I reached out to CDER’s Division of Drug Information Small Business and Industry Assistance to find out. They noted that, because genomic studies have become more common in drug development, particularly as biomarkers for safety or efficacy, submission of such data in the clinical portion of applications has become more routine, and they have not received any voluntary submissions for the past 3 years. They referred me to a paper by Zineh et al. in the June 2010 issue of Nature Reviews Drug Discovery for a summary of submissions made while the voluntary program was more active. The Critical Path Innovation Meeting program has largely replaced the meetings held under the Voluntary Genomic Data Submission program, and is used for non-regulatory meetings on a wide variety of topics. Now we’ll just have to wait and see what updates are proposed for the guidance.
Reach out to me if you want to know more or discuss your medical product development needs.
https://calendly.com/katrinarogers
Text Copyright © 2019 Katrina Rogers