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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER:202049Orig1s000 PRODUCT QUALITY REVIEW(S)MEMORANDUM: DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION
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wwwaccessdatafdagov215498orig1s000chemrcenter for drug evaluation is an online form used by pharmaceutical companies to submit information about their drugs to the FDA for evaluation and approval.
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Information reported on wwwaccessdatafdagov215498orig1s000chemrcenter for drug evaluation includes drug formulation, proposed indications, clinical trial data, adverse event reports, and labeling details.
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