Question 1

The first action for a manufacturer desiring FDA approval for a new drug is to

Accepted Answer

A)   submit a notice of clinical investigation exemption.
B)   perform tests on animals.
C)   perform tests on human beings.
D)   submit a new drug application.
E)   advertise to invite health professionals to report their experiences.

Question 2

Hospitals and other health-care providers are required to report device-related deaths directly to the FDA.

Accepted Answer

A) True 
 B)False

Question 3

Injunction is a legal action that tells individuals or companies to discontinue illegal practices.

Accepted Answer

A) True 
 B)False

Question 4

Which of the following was not a feature of the 1976 Medical Device Amendments?

Accepted Answer

A)   allowed the FDA to require pre-market approval
B)   extended FDA authority over device safety
C)   extended FDA authority over device effectiveness
D)   allowed the FDA to require performance standards
E)   all of the choices are correct E

Question 5

The Better Business Bureaus in the United States encourage truth in advertising and attempt to establish ethical business practices through self-regulation

Accepted Answer

A) True 
 B)False

Question 6

Advertisers are prevented from continuing lucrative promotions because of the fast action taken by the FTC when advertising violations occur.

Accepted Answer

A) True 
 B)False

Question 7

The 1951 Durham-Humphrey Amendment was the first time a distinction was made between over-the-counter and prescription drugs.

Accepted Answer

A) True 
 B)False

Question 8

Few professional, volunteer, or business organizations are involved in health-related consumer protection activities.

Accepted Answer

A) True 
 B)False

Question 9

Advertising played an important role in the growth of patent medicine sales in the United States in the nineteenth century.

Accepted Answer

A) True 
 B)False  True

Question 10

The FDA has established regulations to permit promising investigational drugs to be made available for serious and life-threatening conditions when no alternative is available.

Accepted Answer

A) True 
 B)False

Question 11

The 1960 Federal Hazardous Substances Labeling Act requirements are enforced by the Consumer Product Safety Commission.

Accepted Answer

A) True 
 B)False

Question 12

Cosmetics that are claimed to prevent and cure ailments are subject to the drug provisions of the federal Food, Drug, and Cosmetic Act.

Accepted Answer

A) True 
 B)False

Question 13

Advertising for prescription drugs is regulated by the FDA.

Accepted Answer

A) True 
 B)False

Question 14

The 1990 Safe Medical Devices Act to the Food, Drug, and Cosmetic Act did little to strengthen FDA's ability to monitor the marketplace and order recalls.

Accepted Answer

A) True 
 B)False  False

Question 15

The GRAS list refers to food additives that have been found to be unsafe.

Accepted Answer

A) True 
 B)False

Question 16

The first action against the manufacturer taken by the FTC when it locates a misleading or incorrect advertisement is to

Accepted Answer

A)   request corrective advertising.
B)   request voluntary compliance with modification.
C)   issue a cease and desist order.
D)   issue a preliminary injunction.

Question 17

The FTC is responsible for enforcement of laws relating to advertising of OTC drugs.

Accepted Answer

A) True 
 B)False

Question 18

The FDA will allow the use of a food additive only if it concludes there is practical certainty that no harm will result from normal use over a lifetime.

Accepted Answer

A) True 
 B)False

Question 19

New drugs were not required to be effective as well as safe until 1962.

Accepted Answer

A) True 
 B)False

Question 20

Which of the following problems existing in 1915 are not yet resolved today?

Accepted Answer

A)   inadequate numbers of regulatory staff
B)   small fines relative to the harm caused
C)   advertisements are misleading
D)   all of the choices are not yet resolved
E)   all of the choices are resolved

Exam 21: Consumer Laws, Agencies, and Strategies

The first action for a manufacturer desiring FDA approval for a new drug is to

Correct AnswerverifiedShow Answer

Hospitals and other health-care providers are required to report device-related deaths directly to the FDA.

Correct AnswerverifiedShow Answer

Injunction is a legal action that tells individuals or companies to discontinue illegal practices.

Correct AnswerverifiedShow Answer

Which of the following was not a feature of the 1976 Medical Device Amendments?

Correct AnswerverifiedE

The Better Business Bureaus in the United States encourage truth in advertising and attempt to establish ethical business practices through self-regulation

Correct AnswerverifiedShow Answer

Advertisers are prevented from continuing lucrative promotions because of the fast action taken by the FTC when advertising violations occur.

Correct AnswerverifiedShow Answer

The 1951 Durham-Humphrey Amendment was the first time a distinction was made between over-the-counter and prescription drugs.

Correct AnswerverifiedShow Answer

Few professional, volunteer, or business organizations are involved in health-related consumer protection activities.

Correct AnswerverifiedShow Answer

Advertising played an important role in the growth of patent medicine sales in the United States in the nineteenth century.

Correct AnswerverifiedTrue

The FDA has established regulations to permit promising investigational drugs to be made available for serious and life-threatening conditions when no alternative is available.

Correct AnswerverifiedShow Answer

The 1960 Federal Hazardous Substances Labeling Act requirements are enforced by the Consumer Product Safety Commission.

Correct AnswerverifiedShow Answer

Cosmetics that are claimed to prevent and cure ailments are subject to the drug provisions of the federal Food, Drug, and Cosmetic Act.

Correct AnswerverifiedShow Answer

Advertising for prescription drugs is regulated by the FDA.

Correct AnswerverifiedShow Answer

The 1990 Safe Medical Devices Act to the Food, Drug, and Cosmetic Act did little to strengthen FDA's ability to monitor the marketplace and order recalls.

Correct AnswerverifiedFalse

The GRAS list refers to food additives that have been found to be unsafe.

Correct AnswerverifiedShow Answer

The first action against the manufacturer taken by the FTC when it locates a misleading or incorrect advertisement is to

Correct AnswerverifiedShow Answer

The FTC is responsible for enforcement of laws relating to advertising of OTC drugs.

Correct AnswerverifiedShow Answer

The FDA will allow the use of a food additive only if it concludes there is practical certainty that no harm will result from normal use over a lifetime.

Correct AnswerverifiedShow Answer

New drugs were not required to be effective as well as safe until 1962.

Correct AnswerverifiedShow Answer

Which of the following problems existing in 1915 are not yet resolved today?

Correct AnswerverifiedShow Answer

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E

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True

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False

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