1.2 Evolution of Clinical Trials and the Emergence of Guidance Documents
It took the pharmaceutical
industry many years to reach the relatively mature state of drug development
today. In 1962, the US Congress passed the Kefauver-Harris (KH) Amendment
to the Federal Food, Drug, and Cosmetic Act of 1938 [11]. The amendment
required drug manufacturers to prove the effectiveness and safety
of their drugs in adequate and well-controlled investigations before
receiving marketing approvals. Prior to the amendment, a manufacturer
did not have to prove the effectiveness of a drug before marketing
it.
It is not hard to imagine what drug manufacturers had to go through to comply with the KH Amendment initially. Thanks to the large polio vaccine trials ...
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