For Combination Product Development, Industry Says Talk Is Cheap
Industry official says FDA is responsive to questions from sponsors, but should issue more written guidance to help sponsors make development decisions.
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The meetings are tied to requirements from the 2016 21st Century Cures legislation. They could offer more development certainty for sponsors by allowing informal agreements with the agency on pre- and post-market issues.
Cures legislation offers more development certainty for sponsors by allowing informal agreements with the agency on pre- and postmarket issues.
Pilot project sets timelines for lead and consulting centers that will feed into more substantial changes in PDUFA VI.