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PCE - PCOA Lecture 1 (EXAM 1) Questions And Accurate Answers
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PCE - PCOA Lecture 1 (EXAM 1) Questions AndAccurate Answers
Match the following drug development regulations with the year they were formulated:
1. Trials had to demonstrate safety
2. Trials had to demonstrate efficacy
3. Trials had to present comparative efficacy research
A. 1938
B. 1962
C. 2009 - Answer 1. 1938
2. 1962
3. 2009
Which government department is responsible for protecting the health and providing
essential human services to Americans?
A. Department of Health & Human Services (DHHS)
B. Department of Labor
C. Department of Human Services
D. Department of State - Answer A
Department of Health & Human Services (DHHS) includes:
A. The Food & Drug Administration (FDA)
B. The National Institutes of Health (NIH)
C. Both A & B - Answer C
, This agency carries out laws enacted by congress by promulgating regulations that
become part of the Code of Federal Regulations AND issues guidance statements that
are not legally binding, only recommendations?
A. FDA
B. NIH - Answer A
Match the following sub-divisions of the FDA with their roles/functions:
1. Regulates OTC and Rx drugs
2. Regulates vaccines, blood/components, gene therapy and recombinant therapeutic
proteins
A. Center for Drug Evaluation & Research (CDER)
B. Center for Biologics Evaluation & Research (CBER) - Answer 1. A
2. B
This Agency's mission is to seek fundamental knowledge about the nature and behavior
of living systems & apply that knowledge to enhance health, lengthen life and reduce
illness & disability:
A. FDA
B. NIH - Answer B
The process of approval for drugs is complex & extremely time consuming. It generally
takes 10-15 years & costs in the range of 1.2 - 1.3 billion dollars .
Match the following stages of the process of drug approval with their description.
1. Phase I
2. Phase II
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