"MEDGUIDE" LAW WILL NOT LIMIT AGENCY AUTHORITY IN CASES OF PUBLIC HEALTH RISK, FDA SAYS; CONGRESS/ADMINISTRATION FDA REFORM TALKS CONTINUE DURING RECESS
Executive Summary
FDA's intention to require agency-approved patient information guides for drugs that pose a "serious and significant public health risk" will not be hampered by the "MedGuide" provision signed into law Aug. 7, the agency says.