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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022305Orig1s000 CHEMISTRY REVIEW(S) This is a representation of an electronic record that was signed electronically and this page is the
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What is center for drug evaluation?
The Center for Drug Evaluation and Research is a regulatory body responsible for evaluating and regulating new drug products before they can be marketed in the United States.
Who is required to file center for drug evaluation?
Pharmaceutical companies and drug manufacturers are required to file Center for Drug Evaluation applications for new drug products.
How to fill out center for drug evaluation?
Center for Drug Evaluation applications can be filled out electronically through the FDA's Electronic Submissions Gateway.
What is the purpose of center for drug evaluation?
The purpose of Center for Drug Evaluation is to ensure that new drug products are safe and effective for use by the general public.
What information must be reported on center for drug evaluation?
Center for Drug Evaluation applications must include information on the drug's safety and efficacy, manufacturing process, and proposed labeling.
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