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RAC DRUGS EXAM FINAL QUESTION BANK WITH
COMPLETE 600+ QUESTIONS AND CORRECT
ANSWERS LATEST UPDATE THIS YEAR
Question: Financial Disclosure is required for investigators who, during the time the clinical
investigator is carrying out the study and for one year following the completion of the study,
have:
A. Been a prior employee of the sponsor company and own stock worth more than $50,000 USD
B. Been paid $15,000 USD for conducting clinical trials with the sponsor
C. A spouse who has been paid as a consultant by the company before the study began
D. Is not a requirement for Phase 2 studies - CORRECT ANSWER✔✔A. Been a prior employee of
the sponsor company and own stock worth more than $50,000 USD
Question: 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
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D. Prescription drugs marketed before 1992 - CORRECT ANSWER✔✔C. OTC drugs, cosmetics,
generic drugs and medical devices
Question: 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 - CORRECT ANSWER✔✔C.
Question: 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 - CORRECT
ANSWER✔✔B.
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Question: 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 - CORRECT ANSWER✔✔B. The Federal Food Drug and Cosmetic
Act
Question: Which is not a division of the FDA?
A. CDRH
B. CDER
C. CFER
D. CVM - CORRECT ANSWER✔✔C. CFER
Question: What is the mission of the FDA?
A. Promote public health
B. Protect public health
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C. Pursue international harmonization
D. All of the above - CORRECT ANSWER✔✔D. All of the above
Question: The Freedom of Information Act prohibits FDA from preventing the release of FDA-
generated records:
True or False - CORRECT ANSWER✔✔FALSE
Question: Veterinary drugs are regulated under the Center for Drug Evaluation and Research
(CDER), because the requirements for approval are the same:
True or False - CORRECT ANSWER✔✔FALSE
Question: 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 - CORRECT ANSWER✔✔B. Department, Agency,
Center, Office, Division
RAC DRUGS EXAM FINAL QUESTION BANK WITH
COMPLETE 600+ QUESTIONS AND CORRECT
ANSWERS LATEST UPDATE THIS YEAR
Question: Financial Disclosure is required for investigators who, during the time the clinical
investigator is carrying out the study and for one year following the completion of the study,
have:
A. Been a prior employee of the sponsor company and own stock worth more than $50,000 USD
B. Been paid $15,000 USD for conducting clinical trials with the sponsor
C. A spouse who has been paid as a consultant by the company before the study began
D. Is not a requirement for Phase 2 studies - CORRECT ANSWER✔✔A. Been a prior employee of
the sponsor company and own stock worth more than $50,000 USD
Question: 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
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D. Prescription drugs marketed before 1992 - CORRECT ANSWER✔✔C. OTC drugs, cosmetics,
generic drugs and medical devices
Question: 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 - CORRECT ANSWER✔✔C.
Question: 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 - CORRECT
ANSWER✔✔B.
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Question: 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 - CORRECT ANSWER✔✔B. The Federal Food Drug and Cosmetic
Act
Question: Which is not a division of the FDA?
A. CDRH
B. CDER
C. CFER
D. CVM - CORRECT ANSWER✔✔C. CFER
Question: What is the mission of the FDA?
A. Promote public health
B. Protect public health
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C. Pursue international harmonization
D. All of the above - CORRECT ANSWER✔✔D. All of the above
Question: The Freedom of Information Act prohibits FDA from preventing the release of FDA-
generated records:
True or False - CORRECT ANSWER✔✔FALSE
Question: Veterinary drugs are regulated under the Center for Drug Evaluation and Research
(CDER), because the requirements for approval are the same:
True or False - CORRECT ANSWER✔✔FALSE
Question: 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 - CORRECT ANSWER✔✔B. Department, Agency,
Center, Office, Division
