Under the FDCA, what is required for a drug to be considered “safe and effective”?

For a drug to be classified as "safe and effective" under the Food, Drug, and Cosmetic Act (FDCA), it must go through rigorous testing and evaluation processes. This includes undergoing extensive clinical trials, which are designed to assess the drug's safety profile and therapeutic effectiveness in humans. The data gathered from these trials is then submitted to the FDA as part of the New Drug Application (NDA) process.

The NDA requires comprehensive information about the drug, including the results of the clinical trials, manufacturing details, labeling, and more. The FDA reviews this data to determine if the benefits of the drug outweigh the risks, ensuring that any medication available to consumers has been thoroughly vetted for both safety and effectiveness before reaching the market.

This regulatory framework is critical in maintaining public health, as it ensures that only drugs that have proven they can safely and effectively treat their intended conditions are approved for use. Thus, the requirement of extensive clinical trials and the subsequent review process through the NDA is the foundation for a drug’s classification as "safe and effective."