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FDA History and Definition

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Questions and Answers

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?

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?

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?

To provide incentives for the development of drugs for rare diseases Signup and view all the answers

What was the significance of Dr. Frances Kelsey's actions?

She blocked the US approval of Thalidomide Signup and view all the answers

What was the main consequence of the Drug Price Competition and Patent Term Restoration Act of 1984?

It streamlined the generic drug approval process Signup and view all the answers

What is the primary focus of the FDA in terms of regulation?

Manufacturers of food, drugs, devices, and cosmetics Signup and view all the answers

What amendment distinguishes prescription from non-prescription drugs?

Durham-Humphrey Amendment of 1951 Signup and view all the answers

What is the symbol or legend required on prescription drugs?

Rx Only Signup and view all the answers

What book contributed to the initiation of the Pure Food and Drug Act?

The Jungle Signup and view all the answers

In what year was the Department of Agriculture established?

1862 Signup and view all the answers

What is the name of the act that created the FDA?

Pure Food and Drug Act Signup and view all the answers