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43 Cards in this Set
- Front
- Back
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Which of the following was the first time food and drug regulation was considered in the U.S.?
a) Food, Drug and Cosmetic Act b) Durham-Humphrey Amendment c) The Prescription Drug User Fee Act d) Pure Food and Drug Act |
d) Pure Food and Drug Act
1906 |
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Which of the following established the FDA?
a) Pure Food and Drug Act b) Durham-Humphrey Amendment c) Kefauver-Harris Amendment d) Food, Drug and Cosmetic Act |
a) Pure Food and Drug Act
1906 |
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Which of the following had a goal to protect health and safety associated with unsanitary and poorly labeled food and drugs?
a) Food, Drug and Cosmetic Act b) Durham-Humphrey Amendment c) Pure Food and Drug Act d) FDA Modernization Act |
c) Pure Food and Drug Act
1906 |
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Which of following dealt with adulterated and misbranded food and drugs in interstate commerce?
a) Kefauver-Harris Ammendment b) Pure Food and Drug Act c) Food, Drug and Cosmetic Act d) FDA Modernization Act |
b) Pure Food and Drug Act
1906 |
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Which of the following failed in its laws in 1911?
a) Durham-Humphrey Amendment b) Pure Food and Drug Act c) Food, Drug and Cosmetic Act d) FDA Modernization Act |
b) Pure Food and Drug Act
because of US vs. Johnson and the fraudulent "anti-cancer" intent |
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Which of the following came about as a result of deadly consequences of diethyleneglycol in an anti-infective preparation?
a) Durham-Humphrey Amendment b) Pure Food and Drug Act c) Food, Drug and Cosmetic Act d) FDA Amendment Act |
c) Food, Drug and Cosmetic Act
1938 |
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Which of following required drugs to be safe as labeled & approved by the FDA?
a) Durham-Humphrey Amendment b) Food, Drug and Cosmetic Act c) Kefauver-Harris Amendment d) Pure Food and Drug Act |
b) Food, Drug and Cosmetic Act
1938 |
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Which of the following requires that a label must contain adequate instructions for use and warnings about habit-forming drugs?
a) Food, Drug and Cosmetic Act b) Durham-Humphrey Amendment c) Pure Food and Drug Act d) Kefauver-Harris Amendment |
a) Food, Drug and Cosmetic Act
1938 |
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Which of the following had later amendments that provided for batch uniformity of penicillin and insulin?
a) Food, Drug and Cosmetic Act b) Durham-Humphrey Amendment c) Orphan Drug Act d) Drug Price Competition and Patent Term Restoration Act |
a) Food, Drug and Cosmetic Act
1938 |
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Which of the following laws exempted all drugs made before 1938 from requirement that new drugs be proven safe before marketing?
a) Prescription Drug Marketing Act b) Food, Drug and Cosmetic Act c) Orphan Drug Act d) Drug Price Competition and Patent Term Restoration Act |
b) Food, Drug and Cosmetic Act
1938 |
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T/F?
The Food, Drug and Cosmetic Act of 1938 applied to cosmetics and devices. |
true
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Which of the following established prescription and OTC classes of drugs?
a) Prescription Drug Marketing Act b) Food, Drug and Cosmetic Act c) Durham-Humphrey Amendment d) Kefauver-Harris Amendment |
c) Durham-Humphrey Amendment
1951 |
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Which of the following established the federal caution required on all prescription drug products “Caution: Federal law prohibits dispensing without a prescription”?
a) FDA Modernization Act b) Food, Drug and Cosmetic Act c) Kefauver-Harris Amendment d) Durham-Humphrey Amendment |
d) Durham-Humphrey Amendment
1951 |
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Which of the following lestablished that abels on prescription drugs must contain prescriber’s directions –complies with “adequate directions for use”?
a) Durham-Humphrey Amendment b) FDA Amendment Act c) Kefauver-Harris Amendment d)FDA Modernization Act |
a) Durham-Humphrey Amendment
1951 |
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Which of the following establishes requirements for oral prescriptions and requirements for refills?
a) Pure Food & Drug Act b) FDA Amendment Act c) Durham-Humphrey Amendment d) FDA Modernization Act |
c) Durham-Humphrey Amendment
1951 |
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Which of the following strengthened drug approval process by requiring drugs be proved not only safe but effective?
a) Durham-Humphrey Amendment b) Kefauver-Harris Amendment c) Food, Drug and Cosmetic Act d) Pure Food & Drug Act |
b) Kefauver-Harris Amendment
1962 |
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Which of the following was enacted because of a thalidomide disaster in Europe?
a) Pure Food & Drug Act b) Food, Drug and Cosmetic Act c) Kefauver-Harris Amendment d) Durham-Humphrey Amendment |
c) Kefauver-Harris Amendment
1962 |
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Which of the following gave the FDA control of prescription drug marketing and advertising?
a) Pure Food & Drug Act b) FDA Modernization Act c) Drug Price Competition and Patent Term Restoration Act d) Kefauver-Harris Amendment |
d) Kefauver-Harris Amendment
1962 |
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Which of the following established good manufacturing practices?
a) Kefauver-Harris Amendment b) FDA Amendment Act c) The Prescription Drug User Fee d) FDA Modernization Act |
a) Kefauver-Harris Amendment
1962 |
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Which of the following added more extensive controls for clinical investigations by requiring the informed consent of research subjects and reporting of adverse drug events?
a) Kefauver-Harris Amendment b) FDA Amendment Act c) The Prescription Drug Marketing Act d) FDA Modernization Act |
a) Kefauver-Harris Amendment
1962 |
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Which of the following expanded access to drugs for rare diseases?
a) Drug Price Competition and Patent Term Restoration Act b) Orphan Drug Act c) Prescription Drug Marketing Act d) FDA Modernization Act |
b) Orphan Drug Act
1983 |
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Which of the following allowed for tax and licensing incentives to be granted to manufacturers?
a) Prescription Drug Marketing Act b) The Prescription Drug User Fee Act c) Orphan Drug Act d) FDA Amendment Act |
c) Orphan Drug Act
1983 |
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Which of the following is commonly referred to as the Hatch-Waxman Act?
a) Prescription Drug Marketing Act b) Drug Price Competition and Patent Term Restoration Act c) Orphan Drug Act d) FDA Amendment Act |
b) Drug Price Competition and Patent Term Restoration Act
1984 |
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Which of the following streamlined requirements for bringing generics to market?
a) Prescription Drug Marketing Act b) Orphan Drug Act c) The Prescription User Fee Act d) Drug Price Competition and Patent Term Restoration Act |
d) Drug Price Competition and Patent Term Restoration Act
1984 |
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Which of the following allowed for generic manufacturers to no longer have to perform safety and efficacy tests?
a) Drug Price Competition and Patent Term Restoration Act b) Orphan Drug Act c) The Prescription User Fee Act d) Prescription Drug Marketing Act |
a) Drug Price Competition and Patent Term Restoration Act
1984 |
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Which of the following established sales restriction and recordkeeping requirements for prescription drug samples?
a) The Prescription User Fee Act b) Drug Price Competition and Patent Term Restoration Act c) FDA Modernization Act d) Prescription Drug Marketing Act |
d) Prescription Drug Marketing Act
1987 |
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Which of the following establishes state licensure requirements for pharmaceutical wholesalers?
a) Drug Price Competition and Patent Term Restoration Act b) The Prescription User Fee Act c) Prescription Drug Marketing Act d) FDA Amendment Act |
c) Prescription Drug Marketing Act
1987 |
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Which of the following allowed the FDA to collect fees from companies that produce human drug/biological products?
a) Drug Price Competition and Patent Term Restoration Act b) The Prescription User Fee Act c) Prescription Drug Marketing Act d) FDA Amendment Act |
b) The Prescription User Fee Act
1992 |
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Which of the following is not part of the Prescription Drug User Fee Act?
a) application fees b) product fees c) access fees d) establishment fees |
c) access fees
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Which of the following expedites the drug approval process?
a) Prescription Drug Marketing Act b) FDA Amendment Act c) Drug Price Competition and Patent Term Restoration Act d) The Prescription User Fee Act |
d) The Prescription User Fee Act
1992 |
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Which of the following Streamlined FDA drug approval process to allow expedited availability of drugs and devices?
a) Prescription Drug Marketing Act b) FDA Amendment Act c) FDA Modernization Act d) The Prescription User Fee Act |
c) FDA Modernization Act
1997 |
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Which of the following required FDA to establish public standards regarding approval process and a mission statement?
a) Kafauver-Harris Amendment b) FDA Amendment Act c) FDA Modernization Act d) Durham-Humphrey Amendment |
c) FDA Modernization Act
1997 |
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Which of the following established a fast-track approval process for drugs used for life-threatening diseases?
a) Orphan Drug Act b) FDA Modernization Act c) FDA Amendment Act d) Prescription Drug Marketing Act |
b) FDA Modernization Act
1997 |
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Which of the following established a databank with clinical trial information?
a) FDA Amendment Act b) Prescription Drug Marketing Act c) The Prescription Drug User Fee Act d) FDA Modernization Act |
d) FDA Modernization Act
1997 |
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Which of the following authorized review of clinical investigations?
a) FDA Modernization Act b) The Prescription Drug User Fee Act c) Prescription Drug Marketing Act d) FDA Amendment Act |
a) FDA Modernization Act
1997 |
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Which of the following expands manufacturers’ ability to communicate information regarding off-label uses?
a) Prescription Drug Marketing Act b) FDA Modernization Act c) FDA Amendment Act d) Drug Price Competition and Patent Term Restoration Act |
b) FDA Modernization Act
1997 |
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Which of the following gives FDA full authority to establish labeling requirements for OTC agents?
a) Prescription Drug Marketing Act b) FDA Modernization Act c) Durham-Humphrey Amendment d) Drug Price Competition and Patent Term Restoration Act |
b) FDA Modernization Act
1997 |
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Which of the following established ingredient labeling requirements for inactive ingredients?
a) FDA Amendment Act b) Drug Price Competition and Patent Term Restoration Act c) Prescription Drug Marketing Act d) FDA Modernization Act |
d) FDA Modernization Act
1997 |
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Which of the following reauthorizing PDUFA user fees for drugs and devices for fiscal years 2008‐2012?
a) FDA Amendment Act b) Drug Price Competition and Patent Term Restoration Act c) Prescription Drug Marketing Act d) FDA Modernization Act |
a) FDA Amendment Act
2007 |
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Which of the following requires collection of fees for review of direct‐to-consumer TV ads?
a) The Prescription Drug User Fee Act b) FDA Modernization Act c) Prescription Drug Marketing Act d) FDA Amendment Act |
d) FDA Amendment Act
2007 |
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Which of the following establishes Reagan‐Udall Foundation to promote FDA?
a) The Prescription Drug User Fee Act b) FDA Modernization Act c) FDA Amendment Act d) Prescription Drug Marketing Act |
c) FDA Amendment Act
2007 |
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Which of the following establishes NIH clinical trials registry data bank and clinical trials results database?
a) The Prescription Drug User Fee Act b) FDA Amendment Act c) FDA Modernization Act d) Prescription Drug Marketing Act |
b) FDA Amendment Act
2007 |
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Which of the following established mandatory Risk Evaluation & Mitigation Strategies (REMS)?
a) Drug Price Competition and Patent Term Restoration Act b) FDA Modernization Act c) Prescription Drug Marketing Act d) FDA Amendment Act |
d) FDA Amendment Act
2007 |
