Breakthrough, Fast-Track Pathways Match Their Hype Of Reduced Development Times - JAMA
Executive Summary
Although study was meant to be critical of expedited pathways, it showed that drugs with at least one of the designations experience lower clinical development times.
You may also be interested in...
US FDA's Breakthrough Program Needs Higher Standard For Comparators, NEJM Says
Harvard Medical School researchers call for inclusion of off-label drugs, accelerated approvals, and dietary supplements in the definition of 'existing therapies.'
JAMA Study Continues Wave Of Accelerated Approval Criticism Amid Expansion Of Pathway
Sponsors are increasingly using the accelerated approval pathway, but research continues to be critical about its aspects.
NEJM Takes Aim At Expensive Accelerated Approval Drugs Amid Congressional Drug Pricing Debate
Authors propose imposing penalties on drugmakers who don't start confirmatory trials shortly after accelerated approval and additional discounts for public payers; proposals could pick up steam among congressional democrats amid their renewed call for lower drug prices.