Kevadon (thalidomide), 1960 In 1960, the FDA received a new drug application for a sedative, thalidomide, used for years in other countries to treat a variety of maladies, including morning sickness. FDA medical officer Frances Oldham Kelsey refused to approve the application for lack of sufficient evidence of safety. The drug was soon linked to severe birth defects in thousands of babies. The narrowly averted crisis helped usher in the 1962 Drug Amendments, requiring proof of effectiveness of drugs as well as their safety before marketing.


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