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DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services Center for Drug and Health Plan Choice 7500 Security Boulevard, Mail Stop C42307 Baltimore, Maryland 212441850Center
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The Center for Drug Evaluation and Research (CDER) is a branch of the FDA responsible for evaluating new drugs before they can be sold to the public.
Pharmaceutical companies and other entities involved in the development and marketing of new drugs are required to file with the Center for Drug Evaluation and Research.
To fill out the forms required by the Center for Drug Evaluation and Research, refer to the FDA's guidance documents, complete the application forms accurately, and provide all necessary data regarding safety and efficacy.
The purpose of the Center for Drug Evaluation and Research is to ensure that drugs are safe and effective for the patients who use them.
Information such as the drug's composition, manufacturing process, labeling, and clinical trial data must be reported to the Center for Drug Evaluation and Research.
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