President Signing the 1962 Drug Amendments

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    President John F. Kennedy hands Sen. Estes Kefauver the pen he used to sign the 1962 Amendments to the Federal Food, Drug and Cosmetic (FD&C) Act. Those looking on include Frances Kelsey, second from left, the FDA medical officer who refused to approve the new drug application for Kevadon, the brand name for thalidomide in the United States.

    Following the 1961 thalidomide tragedy in the U.S. President John F. Kennedy signed the 1962 Drug Amendments to the 1938 Food, Drug, and Cosmetic Act. This amendment required that new drugs be approved on the basis of evidence submitted to FDA from pre-marketing clinical studies demonstrating not only safety, but efficacy as well. FDA’s implementation of the new requirement, upheld by the Supreme Court, revolutionized the drug supply of the U.S. in the decades to follow.

    For more information about FDA history visit www.fda.gov/AboutFDA/WhatWeDo/History/default.htm

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