On average, how long does it take for a new drug to move from discovery to FDA approval?

The timeline for a new drug to progress from initial discovery through to FDA approval typically spans about 10 to 15 years. This timeframe includes the various phases of drug development, such as pre-clinical studies, clinical trials (which consist of several phases), and the extensive regulatory review process.

The drug development journey begins with discovery and pre-clinical testing, where researchers identify active compounds and test their effects in lab settings and on animals. Following this stage, companies conduct multiple phases of clinical trials involving human participants to evaluate safety and efficacy. Each phase can take several years to complete due to the rigorous testing requirements and the need to effectively analyze the data collected.

After completing the clinical trials, a New Drug Application (NDA) is submitted to the FDA, which involves a meticulous review process that can extend over a year before a drug receives approval. Given the complexity and the high stakes involved in drug development, the timeline is quite lengthened, but it generally fits within the 10 to 15-year range, making this answer the most accurate reflection of current industry standards.