Perspective
Aug. 27, 2013
FDA still working on 'breakthroughs'
Without a direct window into FDA's decision-making process, it is difficult to say with any certainty the reasons driving FDA's approvals of breakthrough therapy designations. By Robert F. Church and Bert Lao
A significant new opportunity exists for drug and biotechnology companies hoping to bring innovative new therapies to market. The U.S. Food and Drug Administration's new "breakthrough therapy" program offers a number of benefits designed to expedite product review and bring promising treatments to market more quickly. This program was enacted in 2012 as part of the Food and Drug Administration Safety and Innovation A...
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