Prescription Drug Approval Process: U.S.

Prior to 1906, the U.S. federal government had little to do with the monitoring and regulation of medication. However, the 1906 Pure Food and Drug Act, the 1938 Federal Food, Drug, and Cosmetic (FD&C) Act, and the 1962 Kefauver-Harris Amendments to the FD&C Act laid the groundwork for what would become a thorough approval process for prescription drugs sold in the United States. Present-day prescription drug approval in the United States combines private and public development with public regulation. Basic scientists provide initial laboratory work for a new drug, generally performing experiments with animals or with human cells. Then, a drug sponsor (typically a pharmaceutical or biotechnology company) develops a prototype for submission to the U.S. Food and Drug Administration (FDA), which evaluates the drug ...

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