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FDA addresses reviewer goals for modular product submissions

This article was originally published in Clinica

Executive Summary

The FDA has drafted two proposed performance goals to measure progress on review times for modular premarket approval applications. These novel submissions were created in 1998 so that companies could submit preclinical data and manufacturing information for review in sections or modules while still collecting, compiling and analysing their clinical data. MDFUMA codified the new submission but let the agency put off the development of performance goals until later on.

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