This work was done during one weekend by research workshop participants and does not represent the work of Apart Research.
ApartSprints
AI Policy Hackathon at Johns Hopkins University
670822f88b8fdf04a35a4b76
AI Policy Hackathon at Johns Hopkins University
October 28, 2024
Accepted at the 
670822f88b8fdf04a35a4b76
 research sprint on 

Proposal for a Provisional FDA Designation Targeting Biomedical Products Evaluated with Novel Methodologies

Recent advancements in Generative AI and Foundational Biomedical models promise to cut drug development timelines dramatically. With the goal of "Regulating for success," we propose a provisional FDA designation for the accelerated approval of drugs and medical devices that leverage Next Generation Clinical Trial Technologies (NG-CTT). This designation would be awarded to certain drugs provided that they meet some requirements. This policy could be both a starting point for more comprehensive legislation and a compromise between risk and the potential of these new methods.

By 
Gerard Boxo Corominas, Lucia Tortosa Nesterovich
🏆 
4th place
3rd place
2nd place
1st place
 by peer review
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