RAPS RAC Q BANK |ACTUAL QUESTIONS AND
VERIFIED ANSWERS|BRAND NEW 2026-2027
UPDATE|GRADED A+
Question 1
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. Changes in procedures correcting quality problems
The requirement is for corrective and preventative action and only needed if a corrective
action was taken as a result of the investigation. See Sec. 820.198. Complaint Files.
Question 2
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
1
,CORRECT ANSWER
B. Request a Type B meeting as an amendment to the IND
See the CDER/CBER guidance published in February 2000 entitled Formal Meetings With
Sponsors and Applicants for PDUFA Products.
Question 3
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 4
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
CORRECT ANSWER
C. OTC drugs, cosmetics, generic drugs and medical devices
2
,Question 5
MDUFMA is an acronym for:
A. Managing Department for the Unification of Foreign Medicinal Applications
B. Medical Device Users Fee and Modernization Act
C. Modernization of Devices Used for Medical Anomalies
D. Medical Device Universal Fees for Marketing Applications
CORRECT ANSWER
B. Medical Device Users Fee and Modernization Act
Question 6
Which is not a division of the FDA?
A. CDRH
B. CDER
C. CFER
D. CVM
CORRECT ANSWER
C. CFER
Question 7
What is the mission of the FDA?
A. Promote public health
3
, B. Protect public health
C. Pursue international harmonization
D. All of the above
CORRECT ANSWER
D. All of the above
Question 8
The Freedom of Information Act prohibits FDA from preventing the release of FDA-
generated records:
True or False
CORRECT ANSWER
FALSE
Question 9
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 10
Which Congressional Act provided Statutory Authority to FDA to regulate medical devices?
A) Safe Medical Devices Act of 1990 (SMDA)
B) Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
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VERIFIED ANSWERS|BRAND NEW 2026-2027
UPDATE|GRADED A+
Question 1
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. Changes in procedures correcting quality problems
The requirement is for corrective and preventative action and only needed if a corrective
action was taken as a result of the investigation. See Sec. 820.198. Complaint Files.
Question 2
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
1
,CORRECT ANSWER
B. Request a Type B meeting as an amendment to the IND
See the CDER/CBER guidance published in February 2000 entitled Formal Meetings With
Sponsors and Applicants for PDUFA Products.
Question 3
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 4
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
CORRECT ANSWER
C. OTC drugs, cosmetics, generic drugs and medical devices
2
,Question 5
MDUFMA is an acronym for:
A. Managing Department for the Unification of Foreign Medicinal Applications
B. Medical Device Users Fee and Modernization Act
C. Modernization of Devices Used for Medical Anomalies
D. Medical Device Universal Fees for Marketing Applications
CORRECT ANSWER
B. Medical Device Users Fee and Modernization Act
Question 6
Which is not a division of the FDA?
A. CDRH
B. CDER
C. CFER
D. CVM
CORRECT ANSWER
C. CFER
Question 7
What is the mission of the FDA?
A. Promote public health
3
, B. Protect public health
C. Pursue international harmonization
D. All of the above
CORRECT ANSWER
D. All of the above
Question 8
The Freedom of Information Act prohibits FDA from preventing the release of FDA-
generated records:
True or False
CORRECT ANSWER
FALSE
Question 9
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 10
Which Congressional Act provided Statutory Authority to FDA to regulate medical devices?
A) Safe Medical Devices Act of 1990 (SMDA)
B) Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
4
