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Combo Product Review Pilot At US FDA Will Offer All Applications Intercenter Consults

 
• By Michael Cipriano

Agency will collect qualitative and quantitative data to evaluate pilot's success and refine form usability and format, reviewer assignment and general timeline expectations.

The US FDA is alerting combination product sponsors to gear up for the agency's intercenter consult request (ICCR) process, as all combination products will be included in the pilot upon its implementation by mid-2017.

A final process will be established and implemented across the agency by this point in time that will apply to all combination product submissions, FDA spokesman Michael Felberbaum told the...

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