ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Food, Drug, and Cosmetic Act of 1938

Passed after the Elixir Sulfanilamide tragedy, the Food, Drug, and Cosmetic Act required pharmaceutical manufacturers to submit a New Drug Application to prove the drugs safety. The act also provided the basis for the distinction between prescription and nonprescription drugs that was further developed in the Durham-Humphrey Amendment.

Publication Source: Committees on Human Research

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