The promise of an expedited development pathway for “breakthrough therapies” is potentially one of the biggest game-changers to come out of the FDA Safety and Innovation Act, and it has certainly generated excitement among FDA, industry and patient groups. But the promise of speeding innovative medicines to market could be blunted unless issues related to manufacturing, companion diagnostics and international harmonization are adequately addressed.
That was the message from a multi-stakeholder panel discussion at the Nov. 14 Conference on Clinical Cancer Research, co-sponsored by the Friends of Cancer Research and the Engelberg Center for...
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