Legal Definitions - new drug

A new drug is a substance that experts have not yet recognized as safe and effective for use under the conditions prescribed. It can be a natural or synthetic substance intended for use in the diagnosis, cure, treatment, or prevention of disease. The Food and Drug Administration (FDA) must approve all new drugs before they can be marketed.

Examples:

• A pharmaceutical company has developed a new drug to treat a rare form of cancer. Before it can be sold to the public, the FDA must review and approve the drug to ensure its safety and effectiveness.
• A scientist has discovered a new compound that shows promise in treating Alzheimer's disease. The compound must go through rigorous testing and clinical trials before it can be considered a new drug.

These examples illustrate how a new drug must go through a rigorous approval process before it can be marketed to the public. The FDA ensures that new drugs are safe and effective for their intended use, and that they do not pose any significant risks to patients.