The process of getting a new drug approved has a few important steps:

1. Preclinical Testing: This is where everything starts. Scientists work in labs and test on animals to see if the drug is safe and works well. It usually costs over $2.6 billion to do research and development before reaching this point.

2. Investigational New Drug (IND) Application: If the tests in the lab go well, the next step is to submit an IND to the FDA. The FDA takes about 30 days to review this application.

3. Clinical Trials: This part happens in three phases:

   • Phase I: The drug is tested on 20 to 100 healthy people to check if it’s safe.
   • Phase II: 100 to 300 patients take part to see how well the drug works and to find out any side effects.
   • Phase III: This phase includes 1,000 to 3,000 patients to confirm the drug’s effectiveness and watch for any bad reactions.

4. New Drug Application (NDA): If all the trials go well, the developers file an NDA to get approval from the FDA. This usually takes about 10 months.

5. Post-Marketing Surveillance: After the drug is approved, it’s still monitored in the general population to learn about any long-term effects.