Combo Product Review Pilot At US FDA Will Offer All Applications Intercenter Consults
Agency will collect qualitative and quantitative data to evaluate pilot's success and refine form usability and format, reviewer assignment and general timeline expectations.
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US FDA's Office of Combination Products hopes Q&A guidance will help lower high refusal rate on requests for designation.
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.