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US FDA Lays Out High And Low Options At MDUFA Talks

This article was originally published in Clinica

Executive Summary

Minutes from the most recent Medical Device User Fee Act negotiation meeting, posted by the US FDA, suggest regulators and industry are getting closer to agreeing on components of a MDUFA IV proposal. Returning to the negotiating table on May 16, the agency presented two proposals to industry that are approximately $30m apart.

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