Before passage of the Kefauver-Harris Amendment in 1962, manufacturers could begin marketing drugs without proof that they were effective.

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Before the Kefauver-Harris Amendment in 1962, drug manufacturers were not required to prove the effectiveness of their drugs before marketing them; they only needed to demonstrate safety. This amendment mandated that manufacturers provide proof of both safety and effectiveness of their drugs before approval.

Before Passage of the Kefauver-Harris Amendment in 1962, Manufacturers Could