In another initiative based in part on transparency, FDA Commissioner Margaret Hamburg announced that warning letters will no longer necessarily require review and clearance by the chief counsel's office, except for those presenting "significant legal issues." The change is intended to streamline the process to respond to health and safety issues and prioritize follow-up on warning letters. FDA will now generally give no more than 15 days to respond to inspectional findings before issuing a warning letter or thereafter taking other enforcement action (such as a recall, seizure, injunction or criminal prosecution), or else issuing a "close-out" notice to be posted on the FDA Web site that the matter has been resolved. Industry will be well-advised to expect more warning letters and to ensure that it is prepared, not only for an inspection, but for a timely response to any inspectional findings.