Since the Food and Drug Administration Safety and Innovation Act was enacted in July 2012, the Food and Drug Administration (FDA) has received 82 applications under its new breakthrough therapy designation. Of those, 25 designations have been granted and 32 denied. Pharmaceutical company executives speaking during a recent congressional briefing reportedly praised the new approval tool, which is used for drugs that treat a serious or life-threatening disease and have been shown in preliminary clinical trials to demonstrate substantial improvement on a clinically significant endpoint over available therapies. While the review process is accelerated, with the involvement of senior agency management, approval is not guaranteed, according to FDA’s Janet Woodcock. She also apparently noted that the designation can be withdrawn if a better therapy comes to market while the breakthrough drug is still under review. Still, company representatives reported that a breakthrough designation means that communications typically taking weeks and months can be concluded within minutes. See Genetic Engineering & Biotechnology News, September 4, 2013.