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New responsibilities led to US FDA missing PDUFA goals in FY 2008

This article was originally published in SRA

Executive Summary

The US Food and Drug Administration’s performance under its prescription drug user fee programme was not up to the mark in fiscal year 2008, a report has revealed1,2. The agency failed to meet many of the goals it had promised to fulfil under the programme, under which it collects fees from pharmaceutical companies in return for meeting specific review targets.

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