What is the typical time frame from the beginning of a new drug's development to FDA approval?

The typical time frame from the beginning of a new drug's development to FDA approval generally spans around 10 to 15 years, with many estimates citing approximately 12 years as an average duration. This lengthy process includes various stages, such as preclinical research, clinical trials, and the time taken for FDA review.

Development starts with laboratory research and animal testing, which can take several years. Following successful preclinical studies, the drug enters clinical trials that typically consist of three phases, each designed to evaluate safety, efficacy, and dosing. These trials can take several years to complete, often extending to a decade.

Once clinical trials are successfully concluded, the results are compiled into a New Drug Application (NDA) for FDA review, which itself can take another year or more.

The answer indicates a 5-year frame, while closer to the truth reveals that it is more extensive than that, reflecting the comprehensive and rigorous nature of the drug development and approval process. Thus, the suggestion that it takes 5 years does not capture the complexity and the extensive timeline involved.