Posted by Michael Wonder on 20 Apr 2022
Extrapolation of drug indications from study populations by FDA is ‘common’
19 April 2022 - Extrapolation of indications in new drug approvals by the U.S. FDA to populations not originally studied in pivotal clinical trials is a common occurrence, according to a recent investigation published in JAMA Network Open.
Between 2015 and 2017, FDA extrapolated indications for 21 drugs a total of 23 times, Daniel Feldman, of the Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School in Boston, and colleagues said.
