Final answer:
The FDA approves new drugs by conducting large-scale experiments using human subjects to determine their safety and effectiveness. This process can take several years and involves the participation of physicians, scientists, and chemists.
Step-by-step explanation:
The Food and Drug Administration (FDA) in the United States is responsible for approving new drugs. To approve a new drug, the FDA requires a series of large-scale experiments using human subjects to determine if the drug is safe and effective. This process can take several years and involves the participation of physicians, scientists, and chemists.
Researchers must first collect laboratory data from animal trials and submit an Investigational New Drug (IND) application to the FDA. Once the IND is reviewed and approved, clinical trials involving human subjects can begin. During the clinical trials, data on the drug's effectiveness and safety are collected and analyzed. If the drug meets the FDA's standards, the developers can submit a New Drug Application (NDA) that provides details on how the drug will be manufactured, packaged, monitored, and administered.