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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 22-252, Original 1 OTHER REVIEW(S) MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION
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What is center for drug evaluation?
The Center for Drug Evaluation and Research (CDER) is a division of the U.S. Food and Drug Administration (FDA) that is responsible for evaluating and approving new prescription drugs for safety and effectiveness.
Who is required to file center for drug evaluation?
Pharmaceutical companies that develop and manufacture prescription drugs are required to file center for drug evaluation for their new drug products.
How to fill out center for drug evaluation?
Filling out center for drug evaluation involves providing detailed information about the drug's ingredients, manufacturing process, clinical trial results, potential risks and benefits, proposed labeling, and proposed use.
What is the purpose of center for drug evaluation?
The purpose of center for drug evaluation is to ensure that new prescription drugs meet the necessary standards for safety and effectiveness before they can be marketed and sold to the public.
What information must be reported on center for drug evaluation?
Center for drug evaluation requires the reporting of information such as drug composition, manufacturing process, clinical trial data, potential side effects, drug interactions, proposed labeling, and indications for use.
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