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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER:213189Orig1s000 PRODUCT QUALITY REVIEW(S) U.S. FOOD & DRUG ADMINISTRATIONRECOMMENDATION Approval D Approval with Postmarking Commitment D
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The Center for Drug Evaluation and Research (CDER) is a division of the U.S. Food and Drug Administration (FDA) responsible for ensuring that drugs are safe and effective before they are marketed to the public.
Drug manufacturers and sponsors are required to file center for drug evaluation for their products.
Center for drug evaluation can be filled out electronically through the FDA's electronic submission gateway.
The purpose of center for drug evaluation is to provide the FDA with important information about a drug's safety and efficacy.
Center for drug evaluation must include information about the drug's formulation, manufacturing process, clinical trials, and any known side effects.
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