In 1960, at the beginning of her pharmaceutical career, Dr. Frances Kelsey took a courageous stand against granting FDA approval to the drug thalidomide. In spite of pressure from manufacturers, her refusal to permit distribution in the United States was due to a lack of evidence supporting the drug’s safety. Kelsey’s protest prevented an international health crisis from reaching the United States, serving as a turning point in transforming pharmaceutical testing regulations domestically and abroad.
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