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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER:761040Orig1s000 PRODUCT QUALITY REVIEW(S)Center for Drug Evaluation and Research Office of Pharmaceutical Quality Office of Biotechnology
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The Office of Biotechnology Products is a regulatory body responsible for the oversight and regulation of biotechnology products.
Companies and individuals involved in the production and distribution of biotechnology products are required to file with the Office of Biotechnology Products.
The office provides specific instructions and forms for filing biotechnology products, which can be found on their website or requested by contacting the office directly.
The main purpose of the Office of Biotechnology Products is to ensure the safety and efficacy of biotechnology products for consumers and the environment.
Details such as the type of biotechnology product, manufacturing process, potential risks, and intended use must be reported on the office of biotechnology products.
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