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About the Drug Development Process

Many steps are required to ensure the safety and efficacy of a drug before it is approved for use in humans. On average, it costs an estimated $800 million and takes up to 15 years or more for an experimental drug to move from the laboratory to a patient in the United States. For more information, visit the Drug Discovery, Development and Approval Process on the FDA Review website for a comprehensive explanation of this process. View the Animated Drug Discovery Timeline on the PhRMA website.

Drug Discovery