US FDA action on drug shortages yields results, agency improves user fee goals
This article was originally published in SRA
Executive Summary
The first week in May brought mostly good news for the US Food and Drug Administration. Agency chief Margaret Hamburg touted the FDA’s progress in greatly reducing drug shortages, while a congressional watchdog also extolled regulators' improvement in meetings user fee performance goals, although review times increased slightly. The Institute of Medicine, however, had a bone to pick with the agency about its post-approval monitoring practices.