PHR 2500 Quiz 1 With Correct Answers
How does the FDA define a drug? - CORRECT ANSWER✔✔-A substance
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recognized by an official pharmacopoeia or formulary; intended for use in the
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diagnosis, cure, mitigation, treatment, or prevention of disease; intended to
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affect the structure or any function of the body; intended for use as a component
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of medicine
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Distinguish between a drug and a biologic - CORRECT ANSWER✔✔-Drugs are
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tablets, ect, that include small molecules. Biologics are usually injected and
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include proteins that are derived from living systems
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Explain the role of the FDA - CORRECT ANSWER✔✔-The role of the FDA is to
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protect the public, protecting public health by assuring drugs and vaccines
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intended for human use are safe and effective, and advancing public health by
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helping speed medical innovations
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What is the basic organizational structure of the FDA? - CORRECT ANSWER✔✔-
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The Department of Health and Human Services (DHHS) is in charge of the FDA,
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and the FDA is in charge of 8 centers including CDER (drugs) and CBER (biologics)
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Explain what guidances and regulations are and their key differences - CORRECT
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ANSWER✔✔-The FDA interprets acts to make regulations and guidelines; which | | | | | | | | | |
are rules and laws for the pharmacy industry. Regulations are legally bound which
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can lead to due process, and guidances are not legally bound, but breaking them
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can lead to fines.
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How does the FDA define a drug? - CORRECT ANSWER✔✔-A substance
| | | | | | | | | | |
recognized by an official pharmacopoeia or formulary; intended for use in the
| | | | | | | | | | | |
diagnosis, cure, mitigation, treatment, or prevention of disease; intended to
| | | | | | | | | |
affect the structure or any function of the body; intended for use as a component
| | | | | | | | | | | | | |
of medicine
| |
Distinguish between a drug and a biologic - CORRECT ANSWER✔✔-Drugs are
| | | | | | | | | | |
tablets, ect, that include small molecules. Biologics are usually injected and
| | | | | | | | | | |
include proteins that are derived from living systems
| | | | | | |
Explain the role of the FDA - CORRECT ANSWER✔✔-The role of the FDA is to
| | | | | | | | | | | | | | |
protect the public, protecting public health by assuring drugs and vaccines
| | | | | | | | | | |
intended for human use are safe and effective, and advancing public health by
| | | | | | | | | | | | |
helping speed medical innovations
| | |
What is the basic organizational structure of the FDA? - CORRECT ANSWER✔✔-
| | | | | | | | | | |
The Department of Health and Human Services (DHHS) is in charge of the FDA,
| | | | | | | | | | | | | |
and the FDA is in charge of 8 centers including CDER (drugs) and CBER (biologics)
| | | | | | | | | | | | | |
Explain what guidances and regulations are and their key differences - CORRECT
| | | | | | | | | | | |
ANSWER✔✔-The FDA interprets acts to make regulations and guidelines; which | | | | | | | | | |
are rules and laws for the pharmacy industry. Regulations are legally bound which
| | | | | | | | | | | |
can lead to due process, and guidances are not legally bound, but breaking them
| | | | | | | | | | | | | | |
can lead to fines.
| | |
