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. You can also view the Animated Drug Discovery Timeline on the PhRMA website.
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The Drug Discovery, Development and Approval Process
It takes 12-15 years on average for an experimental drug to travel from the lab to U.S. patients. Only five in 5,000 compounds that enter preclinical testing make it to human testing. One of these five tested in people is approved.
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Clinical trial timelines can vary: When looking at clinical trial timelines, it’s important to know that the recruitment process for clinical trials is long and challenging, so the process can take longer than expected. Also, issues like economic problems for the clinical trial company and other world problems can also make timelines longer.