Center for Drug Evaluation and Research 2005 Report to the Nation: Improving Public Health Through Human Drugs

摘要

The Center for Drug Evaluation and Research promotes and protects public health by ensuring that safe and effective drugs are available to Americans. The Food and Drug Administration Modernization Act of 1997 affirmed the centers public health protection role, clarified the FDAs mission and called for the FDA to: Promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of human drugs in a timely manner; Protect the public health by ensuring that human drugs are safe and effective; Participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements and achieve appropriate reciprocal arrangements; and Carry out its mission in consultation with experts in science, medicine and public health and in cooperation with consumers, users, manufacturers, importers, packers, distributors and retailers of human drugs.