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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205931Orig1s000 MICROBIOLOGY / VIROLOGY REVIEW(S) DIVISION OF ANTI-INFECTIVE PRODUCTS CLINICAL MICROBIOLOGY REVIEW NDA 205931 Date review
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What is center for drug evaluation?
Center for Drug Evaluation is the division of the FDA responsible for reviewing and evaluating new drugs before they can be marketed in the United States.
Who is required to file center for drug evaluation?
Drug manufacturers are required to file center for drug evaluation for any new drug they wish to market in the US.
How to fill out center for drug evaluation?
Center for drug evaluation can be filled out electronically on the FDA's website or through submission of a physical application form.
What is the purpose of center for drug evaluation?
The purpose of center for drug evaluation is to ensure that new drugs are safe and effective for use by the public before they are made available on the market.
What information must be reported on center for drug evaluation?
Center for drug evaluation requires detailed information about the drug's composition, manufacturing process, clinical trials results, and potential risks and benefits.
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