In Brief: ICH Guidelines

ICH Guidelines: FDA publishes final ICH guidelines on "Repeated Dose Tissue Distribution Studies, Extent of Population Exposure Required to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Threatening Conditions, Assessment of Systemic Exposure in Toxicity Studies, Dose Selection for Carcinogenicity Studies of Pharmaceuticals, Validation of Analytical Procedures and Clinical Safety Data Management" in the March 1 Federal Register. Written comments for the guidelines, which are effective immediately, may be sent to FDA's Dockets Management Branch, Room 1-23, 12420 Parklawn Drive, Rockville, Md. 20857. Contact Janet Showalter at 301/443-1382 for additional information...