FOOD & DRUG ADMINISTRATION / SCIENCE PHOTO LIBRARY FOOD & DRUG ADMINISTRATION / SCIENCE PHOTO LIBRARY
Editorial use only.
Kennedy signing the 1962 Drug Amendments. Portrait of US President John F. Kennedy (1917-1963) signing the 1962 Drug Amendments to the 1938 Food, Drug, and Cosmetic Act, following the 1961 thalidomide tragedy. Thalidomide was a drug prescribed during the late 1950s and early 1960s to pregnant women as a cure for morning sickness. It was inadequately tested and caused severe birth defects in children. The 1962 amendment required that new drugs be approved on the basis of evidence submitted to the Food and Drug Administration (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, revolutionised the drug supply of the US.
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