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Information for Industry: Drug Approval Process
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The Center for Drug Evaluation and Research's (CDER) job is to ensure that drugs are safe and effective. (See "From Test Tube To Patient: Protecting America's Health Through Human Drugs"). CDER does not test drugs, although the Center's Office of Testing and Research does conduct limited research in the areas of drug quality, safety, and effectiveness. More...
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Investigational New Drug (IND)

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