1|Page
RAC DRUGS FINAL EXAM 2025| BRAND NEW
ACTUAL EXAM WITH 100% VERIFIED QUESTIONS
AND CORRECT SOLUTIONS| GUARANTEED VALUE
PACK| ACE YOUR GRADES.
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 - (answers)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 -
(answers)B.
Following the "elixir of Sulfanilamide" tragedy, public outcry led to the 1938
passage of
,2|Page
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 - (answers)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 - (answers)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 - (answers)C. CFER
,3|Page
What is the mission of the FDA?
A. Promote public health
B. Protect public health
C. Pursue international harmonization
D. All of the above - (answers)D. All of the above
The Freedom of Information Act prohibits FDA from preventing the release of
FDA-generated records:
True or False - (answers)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 - (answers)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 - (answers)B. Department,
Agency, Center, Office, Division
, 4|Page
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 - (answers)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 - (answers)B. Conduct of nonclinical
laboratory studies
A. The regulation does not cover physical or chemical testing
RAC DRUGS FINAL EXAM 2025| BRAND NEW
ACTUAL EXAM WITH 100% VERIFIED QUESTIONS
AND CORRECT SOLUTIONS| GUARANTEED VALUE
PACK| ACE YOUR GRADES.
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 - (answers)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 -
(answers)B.
Following the "elixir of Sulfanilamide" tragedy, public outcry led to the 1938
passage of
,2|Page
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 - (answers)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 - (answers)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 - (answers)C. CFER
,3|Page
What is the mission of the FDA?
A. Promote public health
B. Protect public health
C. Pursue international harmonization
D. All of the above - (answers)D. All of the above
The Freedom of Information Act prohibits FDA from preventing the release of
FDA-generated records:
True or False - (answers)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 - (answers)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 - (answers)B. Department,
Agency, Center, Office, Division
, 4|Page
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 - (answers)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 - (answers)B. Conduct of nonclinical
laboratory studies
A. The regulation does not cover physical or chemical testing
