US Capitol Capsule: 'Breakthrough' fees? FDA urges self-control on requests
This article was originally published in Scrip
Executive Summary
As enticing as it is to seek the FDA's breakthrough therapy designation (BTD), regulators pleaded with industry on 24 April to use some self-control in submitting their requests – noting that reviewing such applications has been an added load on the already overburdened, underfunded agency.