On August 6, 2009, the USFDA's top official Margaret Hamburg vowed to speed up the reporting of warnings related to problems found during inspections and to act more aggressively in serious cases that could harm consumers and patients. The announcement follows criticism of the delays caused by the agency's previous requirement that all warning letters be reviewed by the agency's top lawyer before being sent to manufacturers. This procedure will now only be used for certain legally complex cases. Under the new policy, the agency will strive to send warning letters promptly, whereupon companies will have up to 15 working days to respond before the agency takes further action. Ms. Hamburg also stated that the agency will move quickly to close cases after problems found during inspections have been resolved and that it would make such information public.
For more information, please see: http://www.reuters.com/article/rbssHealthcareNews/idUSN0642179520090806?sp=true