RAC DRUG ONLY ALL PRACTICE EXAM FINAL /COMPLETE EXAM QUESTIONS AND CORRECT ANSWERS (100% CORRECT ANSWERS) A GRADED.
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RAC DRUG
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RAC DRUG
RAC DRUG ONLY ALL PRACTICE EXAM FINAL /COMPLETE EXAM
QUESTIONS AND CORRECT ANSWERS (100% CORRECT ANSWERS)
A GRADED.
RAC DRUG ONLY ALL PRACTICE EXAM FINAL /COMPLETE EXAM
QUESTIONS AND CORRECT ANSWERS (100% CORRECT ANSWERS)
A GRADED.
RAC DRUG ONLY ALL PRACTICE EXAM FINAL /COMPLETE EXAM ...
RAC DRUG ONLY ALL PRACTICE EXAM FINAL /COMPLETE EXAM
QUESTIONS AND CORRECT ANSWERS (100% CORRECT ANSWERS)
A GRADED.
According to the Quality System Regulation, when an investigation of
a complaint is conducted all of the following are requirements for
inclusion in the record of the investigation EXCEPT:
A. The dates and results of the investigation
B. The nature and details of the complaint
C. Changes in procedures correcting quality problems
D. Any reply to the complainant - ANSWER-C.
A regulatory affairs professional wants to schedule a pre-NDA
meeting with FDA. He or she should:
A. Write a letter to FDA requesting a Type A meeting as an
amendment to the IND
B. Request a Type B meeting as an amendment to the IND
C. Call the project manager and set up a date over the phone for a
Type C meeting
D. Email the division director with a list of three dates, 30 days into
the future - ANSWER-B.
Following the "elixir of Sulfanilamide" tragedy, public outcry led to
the 1938 passage of
,A. The Pure Food and Drug Act
B. The Federal Food Drug and Cosmetic Act
C. The Kefauver-Harris Drug Amendments
D. The Public Health Service Act - ANSWER-B. The Federal Food Drug
and Cosmetic Act
What products are exempt from the Prescription Drug User Fees Act
(PDUFA)?
A. Generic drugs only
B. Orphan drugs and cosmetics only
C. OTC drugs, cosmetics, generic drugs and medical devices
D. Prescription drugs marketed before 1992 - ANSWER-C. OTC drugs,
cosmetics, generic drugs and medical devices
Which is not a division of the FDA?
A. CDRH
B. CDER
C. CFER
D. CVM - ANSWER-C. CFER
What is the mission of the FDA?
A. Promote public health
B. Protect public health
C. Pursue international harmonization
,D. All of the above - ANSWER-D. All of the above
The Freedom of Information Act prohibits FDA from preventing the
release of FDA-generated records:
True or False - ANSWER-FALSE
Veterinary drugs are regulated under the Center for Drug Evaluation
and Research (CDER), because the requirements for approval are the
same:
True or False - ANSWER-FALSE
In order of highest level to lowest level, the ranking at US
governmental organizations is:
A. Division, Office, Center, Agency, Department
B. Department, Agency, Center, Office, Division
C. Center, Department, Division, Agency, Office
D. Agency, Center, Office, Department, Division - ANSWER-B.
Department, Agency, Center, Office, Division
For nonclinical studies lasting more than 6 months, quality assurance
audits are conducted at which of the following intervals?
A. 1 month
B. quarterly
C. at completion
D. periodically - ANSWER-D. periodically
, Audits should be conducted at intervals appropriate to assure the
integrity of the study (rules out answers A,B and C). Periodic
auditing by the quality assurance unit is required as appropriate
for the study (21CFR58.35(b)(3)
Good Laboratory Practices Regulations govern the:
A. Conduct and control of laboratory activities
B. Conduct of nonclinical laboratory studies
C. Determination of product efficacy in animals
D. Determination of product feasibility - ANSWER-B. Conduct of
nonclinical laboratory studies
A. The regulation does not cover physical or chemical testing B.
21 CFR 58.3(d) pertains to nonclinical laboratory testing to
determine safety
C. Testing to determine utility is excluded
D. Basic exploratory studies are excluded
Consent from subjects for clinical study enrollment is a:
A. Proposed rule
B. Final rule
C. Recommendation
D. Guideline - ANSWER-B. Final rule
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