Oct 27, 2024
Proposal for a Provisional FDA Designation Targeting Biomedical Products Evaluated with Novel Methodologies
Gerard Boxo Corominas, Lucia Tortosa Nesterovich
Summary
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.
Cite this work:
@misc {
title={
Proposal for a Provisional FDA Designation Targeting Biomedical Products Evaluated with Novel Methodologies
},
author={
Gerard Boxo Corominas, Lucia Tortosa Nesterovich
},
date={
10/27/24
},
organization={Apart Research},
note={Research submission to the research sprint hosted by Apart.},
howpublished={https://apartresearch.com}
}
