Which law regulates the approval and use of new drugs in the U.S.?

The Food, Drug, and Cosmetic Act is the primary legislation that governs the approval and use of new drugs in the United States. Enacted in 1938, this law grants the Food and Drug Administration (FDA) the authority to oversee the safety and efficacy of pharmaceuticals before they can be marketed to the public. The Act requires drug manufacturers to conduct clinical trials to demonstrate the safety and effectiveness of a drug, and they must submit a New Drug Application (NDA) to the FDA for review. The FDA evaluates the data presented, and only if the drug meets the required standards for safety and efficacy will it receive approval for public use.

This fundamental regulation establishes a comprehensive framework for drug approval, ensuring that new medications meet stringent quality and safety guidelines aimed at protecting public health.