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Will accelerated approval, antibiotic add-ons bog down PDUFA?

This article was originally published in Scrip

Executive Summary

In what looked like an attempt to pack as many topics as possible into one hearing, members of the House Energy & Commerce Health Subcommittee on 8 March heard advice over nearly four hours from an array of witnesses on a hodgepodge of proposals that lawmakers are seeking to bundle into the legislation reauthorizing the US FDA's user fee programme.


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