Beat The Breakthrough Therapy Designation Dearth

By Matthew Pillar, Editor, Bioprocess Online

In 2020, the FDA awarded 37 BTDs (Breakthrough Therapy designations). Midway through 2021, it had awarded 17.

Established as a priority review pathway in 2012, the number of BTDs awarded climbed steadily each year until 2019, which set the mark at 74 before the precipitous drop in 2020 (all metrics as of 9/29/21 www.fda.gov).