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FDA Center for Drug Evaluation and Research Small Business and Industry Assistance

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The U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) is charged with ensuring that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. The mission of the CDER Small Business and Industry Assistance (SBIA) is to engage with small pharmaceutical businesses and industry by providing timely and accurate information on human drug development and regulation.