FDA and SEC Crack Down on Pre-Approval Statements
Sep 1, 2004
Unfortunately, companies sometimes violate the public trust by issuing false or misleading statements about FDA-related issues, such as the progress of FDA's pre-market review. When we identify suspected misstatements, we have a new process to bring them to the attention of the SEC staff as quickly and efficiently as possible." Then FDA Commissioner Mark McClellan issued that statement in a February press release.