John Joines is Senior Manager, Regulatory Affairs, Thermo Fisher Scientific, US.
Breakthrough therapy designation: From serious diseases to opioid crisis prevention
Following the human immunodeficiency virus crisis of the 1980s, the US Congress and US Food and Drug Administration (FDA) introduced several regulatory initiatives. The purpose was to expedite FDA review and approval of products to overcome the longer traditional pathway review timelines. One such process enabling faster approval is the ...