South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

How long is the typical FDA new drug approval process?

1. 10 years

2. 15 years

3. 17 years

4. 20 years

The correct answer is: 17 years

The typical FDA new drug approval process often takes about 10 to 15 years from the initial discovery of a drug to its eventual approval. This timeline includes various stages such as preclinical testing, clinical trials (Phase 1, Phase 2, and Phase 3), and the submission of a New Drug Application (NDA) followed by review by the FDA. In some cases, if the drug is particularly complex or if there are significant issues that arise during testing or review, the process can extend even longer. The 17-year timeline reflects the reality that, while many drugs may reach market faster, the complexities of drug development can lead to extended periods before a drug is fully approved and available to the public. This understanding encompasses both the time dedicated to rigorous testing for safety and efficacy and the necessary regulatory review required before a drug can be marketed. Therefore, considering the nuances of drug development and the need for thorough evaluation by the FDA, the typical FDA new drug approval process aligns closely with a timeframe close to 17 years.