vide "an explanation of what the drug is intended to do, how it is believed to work, how it is manufactured and methods and results of all research done so far" (Stanley, 2000, pp. 25-26). After three phases of clinical trials have been satisfactorily completed, the sponsor must file with FDA a new drug application (NDA); however, if FDA took no action on the drug, it could be lawfully marketed. In 1940 FDA became a constituent agency of the Federal Security Agency, the predecessor of the Department of Health, Education and Welfare and the current Department of Health and Human Services.
Postwar Expansion of Powers and Responsibilities
The 1940s were the era of wonder drugs such as antibiotics. The modern pharmaceutical industry was an outgrowth of advances in chemistry which permitted drugs which had previously been produced from natural substances such as plants to be reconstituted as complex molecules and mass produced in the form of pills and vaccines. For example, the German Bayer company synthesized
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