RAC-Drugs Only All Practice Exam Final
2025/2026 Exam Questions and Verified
Answers | Already Graded A+
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
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,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
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,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
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PRIVACY STATEMENT. ALL RIGHTS RESERVED
, 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?
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PRIVACY STATEMENT. ALL RIGHTS RESERVED
2025/2026 Exam Questions and Verified
Answers | Already Graded A+
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
COPYRIGHT©PROFFKERRYMARTIN 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE.
1
PRIVACY STATEMENT. ALL RIGHTS RESERVED
,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
COPYRIGHT©PROFFKERRYMARTIN 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE.
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PRIVACY STATEMENT. ALL RIGHTS RESERVED
,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
COPYRIGHT©PROFFKERRYMARTIN 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE.
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PRIVACY STATEMENT. ALL RIGHTS RESERVED
, 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?
COPYRIGHT©PROFFKERRYMARTIN 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE.
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PRIVACY STATEMENT. ALL RIGHTS RESERVED
