AHPA pushes agency on guidance
This article was originally published in The Tan Sheet
Executive Summary
FDA is urged to publish overdue guidance for reporting serious adverse events in an Oct. 4 letter by the American Herbal Products Association. Under the adverse event law that goes into effect Dec. 22, the guidance should have been published by Sept. 18, AHPA notes. "Congress clearly intended that businesses would have at least 90 days to digest the FDA's guidance and make any necessary changes" to comply with the law, the association says. AHPA also asks the agency to consider exercising enforcement discretion. AHPA provided FDA suggestions on the guidance in August (1"The Tan Sheet" Aug. 20, 2007, p. 13)...