How long does the NDA process typically take from initiation to approval?

The New Drug Application (NDA) process is a lengthy and complex procedure that involves several distinct phases, including extensive preclinical studies, multiple clinical trial phases, review by the Food and Drug Administration (FDA), and the final decision about whether the drug can be marketed. Typically, from the initiation of drug development to the completion of the NDA, the entire process can indeed take approximately 12 to 15 years.

This duration also accounts for the years spent in the research and development phase, where scientists conduct laboratory tests and clinical trials to gather data on safety and efficacy. After the NDA submission, additional time is required for the FDA to thoroughly review the application, which may involve requests for additional information or trials.

This extensive timeline is largely due to the thoroughness required to ensure that new drugs are safe and effective for public use. Factors such as the complexity of the drug itself, the results from clinical trials, and the workload of the reviewing body can all influence the overall duration. Therefore, the timeframe of 12-15 years accurately reflects the typical experience for many drug approvals in the industry.