Industry Collaboration Needed to Address ‘Crisis State’ of Shortages

Drug shortages, poor product quality, poor corrective actions and other “manufacturing breakdowns” have conspired to create a crisis state that demands not only strong regulatory enforcement, but also active collaboration among drugmakers, FDA officials say. “The shortages are the straw that broke the camel’s back for industry and regulators,” Steve Lynn, acting director of CDER’s Office of Manufacturing and Product Quality, said Tuesday.
Washington Drug Letter