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Dec 03, 2012
 |  BioCentury  |  Regulation

Breakthrough promises, pitfalls

Manufacturing, EMA harmonization key for FDA's breakthrough drug pathway

FDA's new breakthrough therapy pathway promises to get truly exceptional new therapies to patients faster, but key players in academia and Europe will need to get on board, and potential manufacturing roadblocks will need to be solved, according to senior agency officials and patient advocacy groups.

The breakthrough therapy pathway was first proposed at a 2011 Friends of Cancer Research/Brookings Institution meeting and was enacted this year as part of the FDA Safety and Innovation Act (FDASIA) that reauthorized prescription drug user fees.

In principle, a potential "breakthrough" drug candidate is one that shows such high magnitude of effect early in development that regulators, healthcare providers and patients not only will want to expedite development, but also reduce the number of patients subjected to ineffective control compounds in clinical trials.

FDASIA requires that FDA set up a process to review applications for breakthrough designations, and take extraordinary steps to collaborate with sponsors to speed the...

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