How much time does it take for a new medication to get FDA approval?

Asked on: 7/21/2025

This question has been asked1times.

The FDA approval process for a new medication typically takes 10-15 years from discovery to market.

Estimated Duration: 5475 days

The FDA approval process involves multiple phases, including preclinical research (1-2 years), clinical trials (Phases 1-3, 6-7 years), FDA review (1-2 years), and post-market monitoring. Factors like drug complexity, trial results, and regulatory requirements affect the timeline. Accelerated pathways exist for critical treatments, but thorough testing ensures safety and efficacy. Pharmaceutical companies must submit extensive data, and the FDA evaluates risks versus benefits before approval.