Question

What happens once the drug has successfully completed phase 3 of the trial?

a) FDA approval for marketing
b) Animal testing
c) Pre-clinical testing
d) Initial safety assessment

Answer 1

Once a drug successfully completes phase 3 of the trial, it can proceed to FDA approval for marketing. This involves large-scale experiments using human subjects to ensure safety and effectiveness. After FDA approval, the drug is monitored for long-term safety and effects in specific patient groups.

Step-by-step explanation:

Once a drug has successfully completed phase 3 of the trial, it can proceed to FDA approval for marketing. This involves a series of large-scale experiments using human subjects to ensure that the drug is safe and effective. Approval from the FDA often takes several years and requires the participation of physicians, chemists, and other scientists.

During this process, researchers collect and analyze data on the drug's effectiveness and safety, including any observed side effects. Once the therapy meets FDA standards, the developers can submit a New Drug Application (NDA) that details how the therapy will be manufactured, packaged, monitored, and administered.

After receiving FDA approval, the drug must continue to be evaluated by a pharmacovigilance system to monitor long-term safety and the drug's effects in specific patient groups.