RAC-DRUGS EXAM 2025
RAC-DRUGS EXAM 2025 WITH GUARANTEED ACCURATE ANSWERS
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 - ACCURATE 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 - ACCURATE ANSWERS✔✔ 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 - ACCURATE 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 - ACCURATE
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 - ACCURATE ANSWERS✔✔ 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 - ACCURATE ANSWERS✔✔ D. All of the above
The Freedom of Information Act prohibits FDA from preventing the
release of FDA-generated records:
True or False - ACCURATE 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 - ACCURATE 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 - ACCURATE
ANSWERS✔✔ 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 - ACCURATE ANSWERS✔✔ D. periodically
Audits should be conducted at intervals appropriate to assure the
integrity of the study (rules out answers A,B and C).
RAC-DRUGS EXAM 2025 WITH GUARANTEED ACCURATE ANSWERS
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 - ACCURATE 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 - ACCURATE ANSWERS✔✔ 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 - ACCURATE 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 - ACCURATE
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 - ACCURATE ANSWERS✔✔ 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 - ACCURATE ANSWERS✔✔ D. All of the above
The Freedom of Information Act prohibits FDA from preventing the
release of FDA-generated records:
True or False - ACCURATE 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 - ACCURATE 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 - ACCURATE
ANSWERS✔✔ 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 - ACCURATE ANSWERS✔✔ D. periodically
Audits should be conducted at intervals appropriate to assure the
integrity of the study (rules out answers A,B and C).
