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59. Which of the following does not conform to FDA standards for food labels:
a. "fresh" means the food is raw or unprocessed
b. "light" means at least one-tenth fewer calories per serving than the regular serving
c. "low calorie" means the product has less than 40 calories per serving per 100 grams
d. "low fat" means the product has 3 grams or less of fat per 100 gram serving
e. all of the other choices are correct
60. According to FDA standards, food that is labeled as "fresh" must NOT have been:
a. processed
b. frozen
c. preserved
d. all of the other specific choices are correct
e. none of the other specific choices are correct
61. According to FDA standards, food that is labeled as "low fat" must:
a. have fewer than 2 grams of fat per serving
b. have 3 or fewer grams of fat per serving
c. not have been processed in more than one way
d. not contain trans fats
e. have fewer than 40 calories per serving
62. According to FDA standards, food that is labeled as "low fat" must:
a. have fewer than 2 grams of fat per serving
b. have fewer than 40 calories per serving
c. not have been processed in more than one way
d. not contain trans fats
e. none of the other choices are correct
63. According to FDA standards, food that is labeled as "low calorie" must:
a. never have been frozen
b. have 3 or fewer grams of fat per serving
c. not have been processed in more than one way
d. not contain trans fats
e. have fewer than 40 calories per serving
64. According to FDA standards, food that is labeled as "low calorie" must:
a. never have been frozen
b. have 3 or fewer grams of fat per serving
c. not have been processed in more than one way
d. not contain trans fats
e. none of the other choices are correct
65. "Old South" potato chips claim to have "that old-fashioned, deep-down satisfyin' taste." They also claim to be low-
fat and low-calorie. According to standards created by the FDA, these chips must:
a. have less fat and fewer calories than their nearest competitor
b. contain fewer than 40 calories per serving
c. contain fewer than 10 grams of fat per serving
d. all of the other specific choices must be met
e. none of the other choices; such rules do not apply to snack foods
66. Which of the following food health claims may be made on labels:
a. the connection between calcium and the prevention of osteoporosis
b. the connection between fiber and reduced risk of heart disease
c. the connection between calcium and the ability to run fast
d. the connection between sodium and strong teeth
e. the connection between fiber and reduced risk of cancer
67. Which of the following health claims may NOT be made on food labels without sufficient documentation by the
seller:
a. the connection between calcium and the prevention of osteoporosis
b. the connection between fat and heart disease
c. the connection between fiber and reduced risk of heart disease
d. the connection between fat and cancer
e. all of the other specific choices may be mentioned on food labels without any extra documentation
68. Which of the following health claims may NOT be made on food labels without sufficient documentation by the
seller:
a. the connection between calcium and the prevention of osteoporosis
b. the connection between fat and heart disease
c. the connection between sodium and high blood pressure
d. the connection between fat and cancer
e. all of the other specific choices may be mentioned on food labels without any extra documentation
69. Comparing regulation of drugs to other countries, the U.S. is:
a. not very strict compared to nations of Europe
b. not very strict compared to most underdeveloped nations
c. one of the strictest nations but has little impact on the world market
d. one of the strictest nations and has great impact on the world market
e. none of the other choices
70. One reason foreign countries adopt FDA standards for drug production is that they want to:
a. export their products to the U.S.
b. export their products to the EU countries
c. import drugs from the U.S.
d. maintain a reputation for low-cost drugs
e. export their products to the EU countries and import drugs from the U.S.
71. A possible benefit of drug regulations in place in many European nations is that:
a. new drugs are introduced to the market more quickly
b. many more drugs may be purchased without a prescription
c. companies wishing to sell in Europe do not need be licensed in each individual country
d. pharmaceutical may be less expensive because companies spend less time getting through administrative
hurdles
e. all of the other choices may be benefits of the European system
72. Drug regulation in China can be problematic because:
a. the Chinese FDA is too strict
b. the Chinese FDA is known to take bribes
c. the Chinese FDA is overstaffed
d. no one in China cares about drug safety
e. none of the other choices are correct
73. The Food, Drug, and Cosmetic Act as passed in 1938:
a. repealed the 1906 Pure Food and Drug Act
b. gave the FDA responsibility to restrict the levels of food additives used
c. allowed the FDA to approve drugs for sale as prescription or non-prescription drugs
d. allowed the FDA to prohibit drugs not demonstrated to be effective
e. all of the other choices
74. The Food, Drug, and Cosmetic Act as passed in 1938:
a. repealed the 1906 Pure Food and Drug Act
b. gave the FDA responsibility to restrict the levels of food additives used
c. required the FDA to monitor nutrition information on food products
d. allowed the FDA to prohibit drugs not demonstrated to be effective
e. none of the other choices
75. The prohibits the sale of any drug until the FDA approves the application submitted by the manufacturer.
a. Food and Medicine Act
b. Food, Drug, and Cosmetic Act
c. Food and Drug Regulation Act
d. Regulation of Food and Drug Act
e. Drug Control Act
76. The prohibits the sale of any drug until the FDA approves the application submitted by the manufacturer.
a. Food and Medicine Act
b. Drug Control Act
c. Food and Drug Regulation Act
d. Regulation of Food and Drug Act
e. none of the other choices are correct
77. Applicants who want to sell a drug in the U.S. market must:
a. submit evidence that the drug is safe for its intended use
b. pay a fee
c. submit evidence that the drug is reasonable for its intended use
d. make the drug affordable for everyone who needs it
e. none of the other choices are correct
78. Nutritional supplements are:
a. subject to the same regulations as drugs
b. subject to stricter regulations than drugs
c. subject to fewer regulations than drugs
d. more expensive than drugs
e. illegal in many states
79. Before passage of the 1938 Food, Drug, and Cosmetic Act, drugs were:
a. all prescribed by physician only
b. all prescribed by pharmacists and physicians
c. regulated by the FDA only if they posed "serious risks" to human health
d. either legal or illegal
e. completely unregulated, you could buy anything
80. Before passage of the 1938 Food, Drug, and Cosmetic Act, drugs were:
a. all prescribed by physician only
b. all prescribed by pharmacists and physicians
c. regulated by the FDA only if they posed "serious risks" to human health
d. completely unregulated, you could buy anything
e. none of the other choices
81. A prescription drug is one that:
a. has serious side effects
b. is expensive
c. requires insurance to purchase
d. may only be used with the permission of a physician
e. may be purchased by anyone
82. A prescription drug is one that:
a. has serious side effects
b. is expensive
c. requires insurance to purchase
d. may be purchased by anyone
e. none of the other choices are correct
83. A drug that may only be used with the permission of a physician is designated as a:
a. special drug
b. regulated drug
c. prescription drug
d. formulated drug
e. regulated drug
84. A drug that may only be used with the permission of a physician is designated as a:
a. special drug
b. regulated drug
c. regulated drug
d. formulated drug
e. none of the other choices are correct
85. Prescription drugs can only be bought at:
a. a pharmacy, with a physician's permission
b. a pharmacy, if the consumer is over 18
c. a pharmacy, if the consumer is over 21
d. a licensed dealer
e. an herbal remedies shop
86. The Food and Drug Administration:
a. prohibits the sale of any drug without a prescription
b. prohibits the sale of drugs without FDA approval
c. prohibits the sale of prescription drugs to anyone under age 19 without parental consent
d. prohibits the sale of any drug without a prescription and prohibits the sale of drugs without FDA approval
e. prohibits the sale of any drug without a prescription and prohibits the sale of drugs without FDA approval and
prohibits the sale of prescription drugs to anyone under age 19 without parental consent
87. The Food and Drug Administration:
a. inspects drug manufacturing facilities
b. prohibits the sale of drugs without FDA approval
c. prohibits the sale of prescription drugs to anyone under age 19 without parental consent
d. inspects drug manufacturing facilities and prohibits the sale of drugs without FDA approval
e. inspects drug manufacturing facilities and prohibits the sale of drugs without FDA approval and prohibits the
sale of prescription drugs to anyone under age 19 without parental consent
88. The Food and Drug Administration does not have which of the following powers:
a. to restrict false advertising of drugs
b. to inspect factories where drugs are manufactured
c. to set the levels of additives that may be used in food
d. to seize drugs that have been approved to be on the market
e. all of the other choices are FDA powers
89. The Food and Drug Administration does not have which of the following powers:
a. to restrict false advertising of drugs
b. to inspect factories where drugs are manufactured
c. to prosecute physicians who violate the learned intermediary rule
d. to seize drugs that have been approved to be on the market
e. all of the other choices are FDA powers
90. The Food and Drug Administration does not have which of the following powers:
a. to restrict false advertising of drugs
b. to inspect plants where drugs are manufactured
c. to decide which drug company will develop which kinds of new drugs
d. to seize drugs that have been approved to be on the market
e. all of the other choices are FDA powers
91. The 1962 Kefauver Amendment to the Food and Drug Act gave the FDA authority for the first time to:
a. approve drugs based on their proven effectiveness
b. license the use of drugs in physician offices
c. determine which drugs are to be prescription drugs
d. approve drugs based on their safety
e. none of the other choices
92. The 1962 Kefauver Amendment to the Food and Drug Act gave the FDA authority for the first time to:
a. ban "hard drugs" such as heroin
b. license the use of drugs in physician offices
c. determine which drugs are to be prescription drugs
d. approve drugs based on their safety
e. none of the other choices
93. The 1962 Kefauver Amendment to the Food and Drug Act gave the FDA authority for the first time to:
a. approve drugs based on their proven effectiveness
b. license the use of drugs in physician offices
c. determine which drugs are to be prescription drugs
d. approve drugs based on their safety
e. all of the other choices
94. The to the Food and Drug Act gave the FDA authority for the first time to approve drugs based on their
proven effectiveness.
a. Kefauver Amendment of 1962
b. Food, Drug and Cosmetics Amendment of 1964
c. Effectiveness Amendment of 1962
d. Madison Amendment of 1962
e. Drug Efficacy Amendment of 1964
95. The average cost of developing a new drug and clearing all FDA regulations to get the drug to market are about a
billion dollars and are:
a. paid by the FDA only if the drug is approved
b. paid by the FDA only if the drug is not approved
c. paid by the FDA whether or not the drug is approved
d. paid by the drug companies
e. paid by the National Institute of Health
96. The average cost of developing a new drug and clearing all FDA regulations to get the drug to market are about a
billion dollars and are:
a. paid by the FDA only if the drug is approved
b. paid by the FDA only if the drug is not approved
c. paid by the FDA whether or not the drug is approved
d. paid by the National Institute of Health
e. none of the other choices
97. The current cost of developing a new drug and clearing all the FDA hurdles to market it is about:
a. $100,000
b. $1 million
c. $5 million
d. $10 billion
e. $1 billion
98. The current time frame for developing a new drug and clearing all the FDA hurdles to market it is about:
a. 5 to 10 years
b. 12 to 15 years
c. 15 to 20 years
d. 1 to 5 years
e. 30 years
99. The main reason that drug companies today produce only about half as many new drugs each year compared to
previous decades is:
a. there are fewer diseases that drugs can be made for
b. people are turning to natural medicine rather than drugs
c. the high cost and long time frame involved in clearing all the FDA hurdles to market a new drug
d. the lack of science majors graduating in the United States
e. the economic downturn
100. Making a new substance that might one day become a marketable drug takes an average of:
a. 2 years
b. 3 years
c. 5 years
d. 7 years
e. 10 years
101. About new compounds make it to Phase I of the tests required to earn FDA approval for the market.
a. 1 in 2,000
b. 1 in 50
c. 1 in 60,000
d. 1 in a million
e. 1 in 450
102. About of new compounds initially tested in the lab make it to the market.
a. 1 in 2,000
b. 1 in 50
c. 1 in 60,000
d. 1 in a million
e. 1 in 100
103. About of the drugs that make it to Phase III of the tests required to earn FDA approval for the market do not
then get final FDA approval.
a. 10%
b. 20%
c. 50%
d. 80%
e. 90%
104. A is an instrument, machine, implant, or other article used in the diagnosis or treatment of a disease in
humans or animals.
a. medical device
b. medical instrument
c. surgical tool
d. drug device
e. none of the other choices are correct
105. medical devices are things presenting minimal potential for harm to the user and are usually of simple design,
such as bandages and gloves.
a. Class I b.
Class II c.
Class III d.
Generic e.
Common
106. Which of the following is true about class I medical devices:
a. the makers are registered with the FDA
b. the goods must be properly manufactured
c. the goods must be properly labeled
d. the goods are not subject to extensive controls
e. all of the other specific choices are correct
107. Which of the following is an example of a class I medical device:
a. gloves
b. wheelchairs
c. x-ray machines
d. surgical materials
e. heart valves
108. Which of the following is an example of a class I medical device:
a. bandages
b. wheelchairs
c. x-ray machines
d. surgical materials
e. heart valves
109. Which of the following is an example of a class II medical device:
a. surgical materials
b. wheelchairs
c. x-ray machines
d. all of the other specific choices are correct
e. none of the other specific choices are correct
110. The most heavily controlled medical devices are:
a. class I
b. class II
c. class III
d. restricted class
e. high class
111. Which of the following is an example of a class III medical device:
a. bandages
b. wheelchairs
c. x-ray machines
d. surgical materials
e. heart valves
112. Which of the following is an example of a class III medical device:
a. bandages
b. wheelchairs
c. x-ray machines
d. surgical materials
e. bone implants
113. Which of the following is an example of a class III medical device:
a. bandages
b. wheelchairs
c. x-ray machines
d. surgical materials
e. pacemakers
114. Which of the following is an example of a class III medical device:
a. heart valves
b. pacemakers
c. bone implants
d. all of the other specific choices are correct
e. none of the other specific choices are correct
115. Every year millions of children are vaccinated against polio. For reasons that are unclear, some children contract
polio from the vaccine, even though their dose was no different than the others. Assume that child who contracts
polio after receiving a vaccine sues the vaccine maker for damages. The likely result of the case will be that:
a. no liability will be imposed because of the public health benefits from the polio vaccine campaign
b. no liability will be imposed because the FDA Act prohibits liability from being imposed on drug producers
who sell FDA approved drugs
c. if the FDA has approved the vaccine, liability may not be imposed due to the learned intermediary doctrine
d. it is uncertain if liability will be imposed; FDA approval is not a shield against liability
e. even if the FDA has approved the vaccine, the rule of strict liability makes the producer legally liable for all
damages
116. In Wyeth v. Levine, where Levine sued the drug developer Wyeth for failure to warn after she lost her forearm
and hand after being given a drug by IV-push, a method known to have risks, the U.S. Supreme Court:
a. dismissed the state court's judgment for Levine because it was impossible for Wyeth to comply with both
federal and state labeling regulations
b. dismissed the state court's judgment for Levine because it was not impossible for Wyeth to comply with both
federal and state labeling regulations
c. upheld the state court's judgment for Levine because it was not impossible for Wyeth to comply with both
federal and state labeling regulations
d. awarded Levine additional damages
e. reversed the state court's decision for Levine and ordered her to pay Wyeth's attorney fees
