The FDA is pursuing several approaches to modernize drug development, with a focus on making the process more efficient while maintaining standards for safety and effectiveness. The agency is also pursuing initiatives intended to streamline development and regulatory processes.

In PHSL’s September poll, AI-enabled drug development was selected by 75% of respondents as the FDA initiative expected to have the greatest long-term impact on healthcare innovation. The results suggest that respondents see AI as having broad potential to influence multiple aspects of drug development, including evidence generation, clinical trials, and development efficiency.

As the FDA modernizes drug development, which FDA initiative do you believe will have the greatest long-term impact on healthcare innovation?

AI-enabled drug development: 75%

Modernized clinical trial designs: 0%

Greater use of real-world evidence: 25%

Faster regulatory review pathways: 0%