Supporting a data-driven approach to regulatory intelligence

Nature Reviews Drug Discovery
Volume 20 Issue 3, March 2021
https://www.nature.com/nrd/volumes/20/issues/3

 

Comment | 28 May 2020
Supporting a data-driven approach to regulatory intelligence
Drug developers are increasingly applying data-driven analysis of the actions of regulatory agencies to gain insights into their expectations and applications of regulatory policy, but such strategies can be limited by the availability and quality of regulatory datasets. Here, we discuss how establishing a single, robust, accessible database of FDA regulatory actions could help address this limitation.
Andrew S. Robertson, Alexis Reisin Miller & Felipe Dolz