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US RAC Review Questions RAPS
Modules Questions and Answers
Latest 2026
In which situation is an IND not required?
A) You intend to conduct a clinical trial with an
investigational new drug
B) You intend to conduct a clinical trial with an approved
drug to support a marketing application for a new
indication
C) You intend to collect blood samples from subjects to
look for biomarkers or pharmacogenetic information
D) You intend to conduct a clinical trial using 2 of your
approved drugs in a new combination Ans: C) You
intend to collect blood samples from subjects to look for
biomarkers or pharmacogenetic information
In the clinical development plan for an investigational
antihypertensive drug, which of the following studies
would typically be conducted first:
A) 1 month repeat dose toxicology study
B) Single dose escalation PK study in healthy volunteers
C) Multiple dose PK study in healthy volunteers
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D) Single dose escalation study in hypertensive patients
Ans: B) Single dose escalation PK study in healthy
volunteers
A sponsor must report an unexpected, fatal or life-
threatening experience believed to be associated with an
unapproved drug/biologic:
A) to FDA, investigators and IRBs within 7 calendar days
B) to FDA and investigators within 7 calendar days
C) to FDA within 14 calendar days
D) to FDA and investigators within 7 working days Ans:
B) to FDA and investigators within 7 calendar days
Which of the following is a covered study as defined
under Financial Disclosure regulations:
A) Phase I dose escalation study
B) Phase I/II Pharmacokinetic Study
C) A large open label safety study conducted at a large
number of study sites
D) Phase III pivotal study Ans: D) Phase III pivotal study
Your company is developing a product to treat a serious
and life threatening disease. A clinically meaningful, well
established primary endpoint will be used in the pivotal
© 2025 All rights reserved
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studies. Which regulatory strategy might you select prior
to commencing Phase 3 studies?
A) Request Special Protocol Assessment
B) Request Fast Track Designation
C) Request Priority Review
D) Approval under Subpart H, Accelerated Approval of
New Drugs for Serious or Life Threatening Illnesses Ans:
A) Request Special Protocol Assessment
As a regulatory affairs professional, you are responsible
for developing the content of an information package for
a Type B meeting with FDA. Your primary objective is to:
A) Reach consensus on content from contributing team
members
B) Ensure content is sufficient to support meeting
objective(s) and questions to FDA
C) Provide appropriate preclinical summary
D) Provide appropriate clinical summary Ans: B) Ensure
content is sufficient to support meeting objective(s) and
questions to FDA
You, a regulatory affairs professional, are assessing the
information to be submitted in support of a marketing
application for a new dosage form for a listed drug. You
lack right of reference to one key preclinical report.
© 2025 All rights reserved
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Which type of application will you prepare for
submission?
A) 505 (b) (1)
B) 505 (b) (2)
C) 505 (j)
D) PMA Ans: B) 505 (b) (2)
8) If FDA were to invoke the Application Integrity Policy,
which of the following is a possible outcome?
A) Defer review of pending application(s)
B) "File" a marketing application at the 60 day review
C) Grant a waiver or deferral for pediatric clinical study
D) Approve a marketing application Ans: A) Defer review
of pending application(s)
9) Which of the following supplements to an approved
NDA/BLA must be approved by FDA prior to distributing
product made using the change?
A) Make change(s) to comply with USP
B) Change in the technical grade of an excipient, same
specifications and use
© 2025 All rights reserved
US RAC Review Questions RAPS
Modules Questions and Answers
Latest 2026
In which situation is an IND not required?
A) You intend to conduct a clinical trial with an
investigational new drug
B) You intend to conduct a clinical trial with an approved
drug to support a marketing application for a new
indication
C) You intend to collect blood samples from subjects to
look for biomarkers or pharmacogenetic information
D) You intend to conduct a clinical trial using 2 of your
approved drugs in a new combination Ans: C) You
intend to collect blood samples from subjects to look for
biomarkers or pharmacogenetic information
In the clinical development plan for an investigational
antihypertensive drug, which of the following studies
would typically be conducted first:
A) 1 month repeat dose toxicology study
B) Single dose escalation PK study in healthy volunteers
C) Multiple dose PK study in healthy volunteers
© 2025 All rights reserved
, 2 | Page
D) Single dose escalation study in hypertensive patients
Ans: B) Single dose escalation PK study in healthy
volunteers
A sponsor must report an unexpected, fatal or life-
threatening experience believed to be associated with an
unapproved drug/biologic:
A) to FDA, investigators and IRBs within 7 calendar days
B) to FDA and investigators within 7 calendar days
C) to FDA within 14 calendar days
D) to FDA and investigators within 7 working days Ans:
B) to FDA and investigators within 7 calendar days
Which of the following is a covered study as defined
under Financial Disclosure regulations:
A) Phase I dose escalation study
B) Phase I/II Pharmacokinetic Study
C) A large open label safety study conducted at a large
number of study sites
D) Phase III pivotal study Ans: D) Phase III pivotal study
Your company is developing a product to treat a serious
and life threatening disease. A clinically meaningful, well
established primary endpoint will be used in the pivotal
© 2025 All rights reserved
, 3 | Page
studies. Which regulatory strategy might you select prior
to commencing Phase 3 studies?
A) Request Special Protocol Assessment
B) Request Fast Track Designation
C) Request Priority Review
D) Approval under Subpart H, Accelerated Approval of
New Drugs for Serious or Life Threatening Illnesses Ans:
A) Request Special Protocol Assessment
As a regulatory affairs professional, you are responsible
for developing the content of an information package for
a Type B meeting with FDA. Your primary objective is to:
A) Reach consensus on content from contributing team
members
B) Ensure content is sufficient to support meeting
objective(s) and questions to FDA
C) Provide appropriate preclinical summary
D) Provide appropriate clinical summary Ans: B) Ensure
content is sufficient to support meeting objective(s) and
questions to FDA
You, a regulatory affairs professional, are assessing the
information to be submitted in support of a marketing
application for a new dosage form for a listed drug. You
lack right of reference to one key preclinical report.
© 2025 All rights reserved
, 4 | Page
Which type of application will you prepare for
submission?
A) 505 (b) (1)
B) 505 (b) (2)
C) 505 (j)
D) PMA Ans: B) 505 (b) (2)
8) If FDA were to invoke the Application Integrity Policy,
which of the following is a possible outcome?
A) Defer review of pending application(s)
B) "File" a marketing application at the 60 day review
C) Grant a waiver or deferral for pediatric clinical study
D) Approve a marketing application Ans: A) Defer review
of pending application(s)
9) Which of the following supplements to an approved
NDA/BLA must be approved by FDA prior to distributing
product made using the change?
A) Make change(s) to comply with USP
B) Change in the technical grade of an excipient, same
specifications and use
© 2025 All rights reserved
