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What was the main objective of the 1938 Federal Food, Drug, and Cosmetic Act?
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 (correct)
- To grant jurisdiction over drug advertising to the Federal Trade Commission
- To prohibit the marketing of adulterated food and drugs
- To regulate drug therapeutic claims
What was the significant consequence of the Thalidomide disaster?
What was the significant consequence of the Thalidomide disaster?
- It resulted in the birth of over 10,000 children with severe defects worldwide (correct)
- It led to the establishment of the FDA
- It prohibited the marketing of non-addictive sedatives
- It mandated regular inspections of production facilities
What was the main provision of the Kefauver-Harris Amendment of 1962?
What was the main provision of the Kefauver-Harris Amendment of 1962?
- The FDA was mandated to conduct regular inspections of production facilities
- Study subjects were required to give their informed consent
- Manufacturers must prove the safety of drug products before they go on the market (correct)
- The FDA was granted 180 days to approve new drug applications
What was the main objective of the Orphan Drug Act of 1983?
What was the main objective of the Orphan Drug Act of 1983?
What was the significance of Dr. Frances Kelsey's actions?
What was the significance of Dr. Frances Kelsey's actions?
What was the main consequence of the Drug Price Competition and Patent Term Restoration Act of 1984?
What was the main consequence of the Drug Price Competition and Patent Term Restoration Act of 1984?
What is the primary focus of the FDA in terms of regulation?
What is the primary focus of the FDA in terms of regulation?
What amendment distinguishes prescription from non-prescription drugs?
What amendment distinguishes prescription from non-prescription drugs?
What is the symbol or legend required on prescription drugs?
What is the symbol or legend required on prescription drugs?
What book contributed to the initiation of the Pure Food and Drug Act?
What book contributed to the initiation of the Pure Food and Drug Act?
In what year was the Department of Agriculture established?
In what year was the Department of Agriculture established?
What is the name of the act that created the FDA?
What is the name of the act that created the FDA?
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