QUESTION IMAGE
Question
which of these fda regulations required that manufacturers disclose possible dangers and side effects of their medicines?
a kefauver - harris amendment
b. food and drug safety act
c. virus toxins law
d. durham - humphrey amendment
please select the best answer from the choices provided
a
b
c
d
The Kefauver - Harris Amendment (1962) was a significant amendment to the Federal Food, Drug, and Cosmetic Act. It required that manufacturers disclose possible dangers and side effects of their medicines. This was in response to issues such as the thalidomide tragedy. The Food and Drug Safety Act is a more general - term and not the specific act for this requirement. The Virus Toxins Law is related to biological products like virus - derived toxins. The Durham - Humphrey Amendment was mainly about the distinction between prescription and non - prescription drugs.
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A. Kefauver - Harris Amendment