FDA wants faster compliance
This article was originally published in The Silver Sheet
Companies must speed up responses to regulatory problems, CDRH Office of Compliance Director Tim Ulatowski said at the 2009 Parenteral Drug Association/FDA Joint Regulatory Conference, held Sept. 14-18 in Washington, D.C. "Today is a new day at FDA," Ulatowski said. "The commissioner's message is very plain, very clear." When it comes to product recalls, "the press release goes [out] today. The action is taken today," he said. "Industry has to get up to the speed that the agency is now working. Otherwise, you're going to be totally shocked at the response you're getting over the phone or in person from us.
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