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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER:203441Orig1s000 MICROBIOLOGY REVIEW(S)Product Quality Microbiology Review 29 MARCH 2012 NDA: 203441/N001 Drug Product Name Proprietary: GATT

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What is review - drug approval?

Review - drug approval is the process in which regulatory authorities evaluate the safety and efficacy of a drug before granting approval for its marketing and sale.

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Pharmaceutical companies are required to file review - drug approval for their new drugs or for changes to existing drugs.

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Information such as preclinical and clinical data, manufacturing process, labeling information, and any adverse events must be reported on review - drug approval.

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