Performance Improvement 2003. Center for Drug Evaluation and Research

01/01/2003

CDER 2001 Report to the Nation: Improving Public Health Through Human Drugs

The Center promotes and protects public health by assuring safety and effectiveness of drugs used by Americans. The Food and Drug Administration (FDA) Modernization Act of 1997 affirmed the center’s public health protection role, clarified the FDA’s mission and called for the FDA to do the following: (1) promote public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of human drugs in a timely manner, (2) protect the public health by ensuring that human drugs are safe and effective, (3) participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements and achieve appropriate reciprocal arrangements, and (4) 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. Among many findings, this report states that: (1) people with cancer, heart disease, HIV, AIDS, and other serious conditions have benefited from FDA approvals in 2001; FDA met its obligations to Congress for prompt and thorough review of drug applications supported by user fees; (2) with modern, state-of-the-art tools and techniques, FDA was  able to detect rare and unexpected risks more rapidly and take corrective action more quickly; and FDA augmented its risk assessment ability by gaining access to user fee data. http://www.fda.gov/cder/reports/rtn/2001/rtn2001.pdf

FEDERAL CONTACT: Debbie Henderson, 301-443-5281 PIC ID: 7890

PERFORMER: Food and Drug Administration, Rockville MD

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