12 Questions
What was the main objective of the 1938 Federal Food, Drug, and Cosmetic Act?
To require manufacturers to demonstrate the safety of new drugs prior to marketing
What was the significant consequence of the Thalidomide disaster?
It resulted in the birth of over 10,000 children with severe defects worldwide
What was the main provision of the Kefauver-Harris Amendment of 1962?
Manufacturers must prove the safety of drug products before they go on the market
What was the main objective of the Orphan Drug Act of 1983?
To provide incentives for the development of drugs for rare diseases
What was the significance of Dr. Frances Kelsey's actions?
She blocked the US approval of Thalidomide
What was the main consequence of the Drug Price Competition and Patent Term Restoration Act of 1984?
It streamlined the generic drug approval process
What is the primary focus of the FDA in terms of regulation?
Manufacturers of food, drugs, devices, and cosmetics
What amendment distinguishes prescription from non-prescription drugs?
Durham-Humphrey Amendment of 1951
What is the symbol or legend required on prescription drugs?
Rx Only
What book contributed to the initiation of the Pure Food and Drug Act?
The Jungle
In what year was the Department of Agriculture established?
1862
What is the name of the act that created the FDA?
Pure Food and Drug Act
Learn about the Food and Drug Administration, its role in consumer protection, and its responsibilities in regulating the manufacturing and distribution of drugs, food, devices, and cosmetics. Understand the FDA's focus and limitations in the industry.
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