Working With FDA on a PMA Approval

Published on January 29, 2016
Categorized as Submissions

Appealing to a higher power

We assisted a client in negotiating with FDA the clinical trial endpoints, a diagnostic algorithm, inclusion and exclusion criteria, control, how to eliminate for bias, and a shortened follow-up period that saved the company two years and $32MM in additional cost (burn rate and out-of-pocket expense). We did it by elevating the matter to senior management for resolution.  We were able to do this while avoiding an FDA panel meeting.

 

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Helping clients be appropriately aggressive, yet compliant. TM