The FDA was given the authority to review the effectiveness and safety of a new drug before it could be marketed.

Question

Quizplus · Accepted Answer

The Kefauver-Harris Drug Amendments of 1962 gave the FDA the authority to require drug manufacturers to prove the effectiveness and safety of a new drug before it could be marketed. This was a significant change from previous laws, such as the Food and Drugs Act of 1906 and the Food, Drug, and Cosmetic Act of 1938, which focused more on preventing adulterated or misbranded drugs from entering the market. The Prescription Drug User Fee Act of 1992 established user fees for drug manufacturers to help fund the FDA's drug review process, but did not significantly change the FDA's authority to review the effectiveness and safety of new drugs.

The FDA Was Given the Authority to Review the Effectiveness