CCC Responds to FDA Request for Feedback on Using AI and ML in the Development of Drug and Biological Products » CCC Blog

On July 10, CCC responded to a Request for Feedback released by the Food and Drug Administration (FDA) on Using AI and ML in the Development of Drug and Biological Products. The response was written by two CCC Council Members of CCC’s Computational Challenges in Health Task Force, David Danks (University of California, San Diego), and Mona Singh (Princeton University), and former Council Member Kevin Fu (Northeastern University).

The FDA’s Center for Drug Evaluation and Research (CDER), in collaboration with the Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH), including the Digital Health Center of Excellence (DHCoE), released a discussion paper and subsequent questions relating to considerations and practices for AI/ML in drug development. The discussion questions, and CCC’s response, are divided into the following categories: (1) Human-led governance, accountability, and transparency, (2) Quality, reliability, and representativeness of data, and (3) Model development, performance, monitoring, and validation. Read CCC’s full response here.

The deadline to submit comments to the FDA’s request is August 9, so community members still have plenty of time to write a response.