RAC DRUGS EXAMINATION TEST VERIFIED
QUESTIONS AND SOLUTIONS GRADED A+
●● 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
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
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
●● 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?
A. 1 month
B. quarterly
C. at completion
D. periodically
Answer: 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
Answer: B. Conduct of nonclinical laboratory studies
QUESTIONS AND SOLUTIONS GRADED A+
●● 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
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
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
●● 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?
A. 1 month
B. quarterly
C. at completion
D. periodically
Answer: 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
Answer: B. Conduct of nonclinical laboratory studies
