Premarket Safety Population Size Associated with Approval of Expedited Program Drugs and Orphan Drugs

For approved expedited program and orphan drugs, the safety populations used for premarket drug risk assessments are often limited in size. The study ’s objective was to determine whether large safety populations, with the capacity for excluding uncommon adverse drug effects, influenced approval of these drugs for patients use.

Source: Journal of Clinical Epidemiology - May 14, 2019 Category: Epidemiology Authors: Kachi Illoh Tags: Letter to the editor Source Type: research