The ________ is a federal law that gives the FDA broad powers to license new drugs in the United States.

Question

Quizplus · Accepted Answer

The Drug Amendment to the FDCA (Food, Drug, and Cosmetic Act) is also known as the Kefauver-Harris Amendment. It was passed in 1962 and established requirements for drug efficacy and safety, requiring manufacturers to prove that their drugs were not only safe but also effective before they can be marketed. It gave the FDA the power to regulate drug testing and required drug manufacturers to report adverse effects of their drugs.

The ________ Is a Federal Law That Gives the FDA