Module 1.1 PHR 2500 EXAM QUESTIONS WITH COMPLETE SOLUTIONS

Module 1.1 PHR 2500 EXAM QUESTIONS
WITH COMPLETE SOLUTIONS

Describe a drug & biologic and key milestones in FDA regulations for clinical trials.
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- CORRECT ANSWER✔✔-Look at the graph in notes
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How does the FDA define a drug? - CORRECT ANSWER✔✔--official pharmacopeia
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or formula
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-intended for use in the diagnosis, cure, mitigation, treatment, or prevention of
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disease |




- affect the structure or any function of the body
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-component of medicine. | |




Distinguish between a drug and a biologic. - CORRECT ANSWER✔✔-Biologics are
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made from natural products. and have a much larger therapeutic agent
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Explain the role of the FDA. - CORRECT ANSWER✔✔--Protecting public health
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from radiation
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-assure food is safe and properly labeled
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-regulate tobacco |




What is the basic organizational structure of the FDA? - CORRECT ANSWER✔✔-
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CDER (drugs), CBER (biologics), other centers
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