3. Following the discovery that thalidomide causes severe birth defects, which federal drug law requires manufacturers to provide proof of both safety and efficacy before marketing in the United States?

A. Food Drug and Cosmetic Act (1938)
B. Kefauver-Harris Amendment (1962)
C. Food and Drug Act (1906)
D. Harrison Tax Act (1914)

Question

23-06-2024
Health

Answered

3. Following the discovery that thalidomide causes severe birth defects, which federal drug law requires manufacturers to provide proof of both safety and efficacy before marketing in the United States?

A. Food Drug and Cosmetic Act (1938)
B. Kefauver-Harris Amendment (1962)
C. Food and Drug Act (1906)
D. Harrison Tax Act (1914)

Answer :

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GinnyAnswer GinnyAnswer · Answer 1 · 2024-06-23T15:18:22-04:00

Final answer:

The Kefauver-Harris Amendment (1962) mandates drug manufacturers to prove safety and efficacy before marketing in the U.S. post the thalidomide discovery.

Explanation:

Kefauver-Harris Amendment (1962) is the federal drug law that requires manufacturers to provide proof of both safety and efficacy before marketing in the United States. This amendment was a response to the thalidomide tragedy and aimed to ensure thorough testing of drugs to prevent similar incidents.

Learn more about FDA drug law regulations and the thalidomide tragedy here:

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