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Breakthrough encore

Friends of Cancer Research proposing breakthrough companion diagnostics

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.

Senior agency officials, including Jeffrey Shuren, director of the Center for Devices and Radiological Health (CDRH), and Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), made it clear they support the proposal in principle at a Sept. 6 meeting sponsored by FOCR and the Alexandria Center for Life Science.

Shuren suggested, however, that supporting the breakthrough diagnostics program may require additional funding.

CDRH wasn't at the table when the breakthrough therapies program was developed, and the center has not received any additional funds to help it speed the review of breakthrough companion diagnostics applications, he noted.

Shuren said the center has been able to handle

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