OR WAIT null SECS
© 2023 MJH Life Sciences™ and Applied Clinical Trials Online. All rights reserved.
Applied Clinical Trials
Nearly all later entrants to drug classes had begun clinical testing or were in regulatory review in the United States before the first drug within a pharmacologic class was approved, a newly completed analysis from the Tufts Center for the Study of Drug Development suggests.
The analysis looked at 40 pharmacologic classes and included drugs and biologics between the 2005 - 2011 period, where 90% of all later-in-class drugs had at least initiated Phase I clinical testing anywhere in the world or had filed an investigational new drug application with the U.S. Food and Drug Administration (FDA) before FDA approval for the first-in-class drug, according to Tufts CSDD.
Key findings from the studies, reported in the November/December Tufts CSDD Impact Report, included the following: