Posted by Michael Wonder on 18 Jan 2023
FDA’s breakthrough program: faster drug OKs without sacrificing safety
18 January 2023 - A FDA program markedly cut the time and cost of bringing to market new drugs, without increasing the likelihood of adverse reactions, according to research in progress published by the National Bureau of Economic Research.
The FDA’s breakthrough therapy designation, started in 2012 mainly to get drugs for treating serious diseases out more quickly, shortened clinical development times by 23%, according to the working paper by Harvard’s Amitabh Chandra, UCLA Anderson’s Jennifer Kao, FDA’s Kathleen L. Miller, and Harvard’s Ariel D. Stern.
