Will accelerated approval, antibiotic add-ons bog down PDUFA in US?
This article was originally published in SRA
Executive Summary
In what looked like an attempt to pack as many topics as possible into one hearing, members of the US House Energy & Commerce Health Subcommittee on 8 March heard advice over nearly four hours from an array of witnesses on a mix of proposals that lawmakers are seeking to bundle into the legislation reauthorising the Food and Drug Administration's prescription drug user fee programme1.