Final answer:
The FDA approval process ensures the efficacy and safety of a new drug before it becomes commercially available. It involves laboratory data collection, IND application, clinical trials, and NDA submission.
Step-by-step explanation:
Before a new drug can become commercially available, it must undergo FDA approval to ensure its efficacy and safety. This process involves several stages, including laboratory data collection from animal trials and submission of an Investigational New Drug (IND) application. Once the IND is reviewed and approved, clinical trials with human subjects can begin to further evaluate the drug's effectiveness and safety.
The clinical trial phase involves collecting and analyzing data on the drug's performance, including any observed side effects. If the drug meets FDA standards, the developers can then submit a New Drug Application (NDA) that provides detailed information on the drug's manufacturing, packaging, monitoring, and administration.
Even after receiving FDA approval, the drug continues to be evaluated through a pharmacovigilance system, ensuring long-term safety and monitoring its effect on specific patient subgroups.