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Manufacturing, EMA harmonization key for FDA's breakthrough drug pathway
Breakthrough promises, pitfalls
Monday, December 3, 2012
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
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.
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