Drug safety guidance

Executive Summary

FDA has abandoned its original idea for a Drug Watch Web site and will instead post drug safety information on a Drug-Specific Information Web site on the Center for Drug Evaluation and Research home page, the agency announces in a final guidance released March 2. Drug sponsors will be notified that emerging drug safety data will be posted at least 24 hours before the information is communicated, the agency adds. The guidance, which outlines how FDA plans to communicate drug safety information to the public, follows a May 2005 draft guidance, which proposed having Drug Watch list drugs considered as having significant emerging safety risks. However, many comments received by the agency stated that such a name might create confusion with the current MedWatch program. The Consumer Healthcare Products Association stated in its own comments on Drug Watch that information should be posted only after its significance had been "fully determined" (1"The Tan Sheet" Aug. 15, 2005, p. 3)...