Document Type

Article

Publication Date

2012

ISSN

0028-4793

Publisher

Massachusetts Medical Society

Language

en-US

Abstract

Food and Drug Administration (FDA) rules are often forged in crisis. After the 1937 sulfanilamide disaster that killed more than 100 people, Congress passed the Food, Drug, and Cosmetic Act (FDCA),requiring drugs to be safe and properly labeled. In 1962, a requirement was introduced for proof of drug efficacy through “adequate and well-controlled investigations,” partly in response to the thalidomide tragedy. Rules protecting human-research subjects owe a debt to Tuskegee and Nuremberg.

Comments

From The New England Journal of Medicine, Kevin Outterson, Regulating Compounding Pharmacies after NECC, Volume 367, Page 1969 Copyright ©(2012) Massachusetts Medical Society. Reprinted with permission.

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