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

Explanation:

1. The Kefauver-Harris Amendment (1962) mandated that drug manufacturers prove their drugs are both safe and effective, and required clear disclosure of all risks, side effects, and proper usage information on medication labeling.
2. The Food and Drug Safety Act is not a major named FDA regulation focused on side effect disclosure.
3. The Virus Toxins Law regulates the handling of virus toxins, not drug labeling.
4. The Durham-Humphrey Amendment differentiates between prescription and over-the-counter drugs, not side effect disclosure.

Answer:

A. Kefauver-Harris Amendment