Breakthrough encore

Friends of Cancer Research, the advocacy organization that conceived of and persuaded Congress to enact FDA's breakthrough therapies program, last week unveiled a proposal to expedite development of companion diagnostics that are intended for use with a breakthrough drug.

In contrast to the breakthrough therapies program, which was incorporated into the FDA Safety and Innovation Act, FOCR's new proposal focuses on steps the agency and diagnostics companies can take to streamline development and review within existing law...