Important changes to the regulation of drugs by the Food and Drug Administration occurred in 1938 and 1962,largely in response to

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The Elixir Sulfanilamide poisonings in 1937, which caused over 100 deaths, and the birth defects from thalidomide in the early 1960s were major public health crises that led to significant changes in drug regulation by the FDA. These tragedies highlighted the need for increased oversight and testing of drugs before they could be marketed to the public. Both incidents led to significant changes in FDA regulations, including the requirement for pre-market approval and rigorous testing of drugs.

Important Changes to the Regulation of Drugs by the Food