FDA drug regulation workshop

Executive Summary

FDA will hold a two-day public meeting June 8-9 to provide information about drug and device regulation to the regulated industry. Called "Drugs and Devices - Promoting and Protecting the Public Health Through Risk Management and Product Cycle Improvement," the workshop will address: a risk management approach to consumer protection and industry regulation; how quality management systems (including corrective and preventive action) contribute to product cycle improvement; supplier management and component controls for drugs and devices; adverse drug event reporting requirements; medical device reporting requirements; recalls, corrections and removals; and complaint handling from the FDA investigator's perspective