RAC-Drugs Exam Test Bank | 500 Questions with Verified Answers |100% Correct| Latest 2025/2026.

RAC-Drugs Exam Test Bank | 500 i,- i,- i,- i,- i,- i,-




Questions with Verified Answers i,- i,- i,- i,-




|100% Correct| Latest 2025/2026. i,- i,- i,-




What is the mission of the FDA?
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A. Promote public health
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B. Protect public health
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C. Pursue international harmonization
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D. All of the above
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The Freedom of Information Act prohibits FDA from preventing
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the release of FDA-generated records:
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i,- True or False i,- i,- i,-i,- i,- FALSE


Veterinary drugs are regulated under the Center for Drug
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Evaluation and Research (CDER), because the requirements for
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approval are the same: i,- i,- i,-




i,- True or False i,- i,- i,-i,- i,- FALSE

,In order of highest level to lowest level, the ranking at US
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governmental organizations is: i,- i,-




A. Division, Office, Center, Agency, Department
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B. Department, Agency, Center, Office, Division
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C. Center, Department, Division, Agency, Office
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D. Agency, Center, Office, Department, Division
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Department, Agency, Center, Office, Division i,- i,- i,- i,-




For nonclinical studies lasting more than 6 months, quality
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assurance audits are conducted at which of the following
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intervals?


A. 1 month
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B. quarterly
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C. at completion
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D. periodically
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Audits should be conducted at intervals appropriate to assure the
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integrity of the study (rules out answers A,B and C).
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Periodic auditing by the quality assurance unit is required as
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appropriate for the study (21CFR58.35(b)(3) i,- i,- i,- i,-

,Good Laboratory Practices Regulations govern the:
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A. Conduct and control of laboratory activities
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B. Conduct of nonclinical laboratory studies
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C. Determination of product efficacy in animals
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D. Determination of product feasibility
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nonclinical laboratory studies i,- i,-




A. The regulation does not cover physical or chemical testing
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B. 21 CFR 58.3(d) pertains to nonclinical laboratory testing to
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determine safety i,-




C. Testing to determine utility is excluded
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D. Basic exploratory studies are excluded
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Consent from subjects for clinical study enrollment is a:
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A. Proposed rule
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B. Final rule
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C. Recommendation
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D. Guideline
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, The FDA regulation on informed consent became a final rule on
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27 January 1981 (21 CFR 50)
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All of the following are requirements of an IRB, EXCEPT
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A. Has at least 5 members
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B. Includes at least 1 nonscientific member
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C. Obtains informed consent from all subjects
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D. Represents the cultural mix of the community
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informed consent from all subjects i,- i,- i,- i,-




A. It is a requirement that each IRB have at least 5 members (21
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CFR56.107(a)
B. The regulations require each IRB to have at least 1 member
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whose primary concerns are in the scientific area and at least 1
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whose primary concerns are in nonscientific areas ((21
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CFR56.107(c)
C. It is the responsibility of the clinical investigator to obtain
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consent from all subjects, not the IRB (21 CFR 312.60)
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D. The regulations require each IRB to have a diversity of
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members (race, gender, cultural backgrounds ) (21 CFR56.107(a)
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