Regulatory Authorities

When a nation regulates drugs, devices, biologics, cosmetics, foods, water, the government delegates oversight to regulatory authorities. In the United States of America, Congress passes laws on what is regulated, and by how much, and the Food and Drug Administration decides which drug, device, biologic will be approved for human therapeutic use. Cosmetics are not regulated.

Some documents about regulatory authorities are included in a pages I prepared when Medical Writing Institute was in its early years. These have been updated. They give a general idea of the documents prepared for regulatory authorities, click here