US RAC EXAM RAPS MODULES |ACTUAL
QUESTIONS AND VERIFIED ANSWERS|BRAND NEW
2026-2027 UPDATE|GRADED A+
Question 1
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
CORRECT ANSWER
C) You intend to collect blood samples from subjects to look for biomarkers or
pharmacogenetic information
Question 2
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
D) Single dose escalation study in hypertensive patients
CORRECT ANSWER
B) Single dose escalation PK study in healthy volunteers
1
,Question 3
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
CORRECT ANSWER
B) to FDA and investigators within 7 calendar days
Question 4
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
CORRECT ANSWER
D) Phase III pivotal study
Question 5
2
,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 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
CORRECT ANSWER
A) Request Special Protocol Assessment
Question 6
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
CORRECT ANSWER
B) Ensure content is sufficient to support meeting objective(s) and questions to FDA
Question 7
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. Which type of application will you prepare for
submission?
3
, A) 505 (b) (1)
B) 505 (b) (2)
C) 505 (j)
D) PMA
CORRECT ANSWER
B) 505 (b) (2)
Question 8
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
CORRECT ANSWER
A) Defer review of pending application(s)
Question 9
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
4
QUESTIONS AND VERIFIED ANSWERS|BRAND NEW
2026-2027 UPDATE|GRADED A+
Question 1
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
CORRECT ANSWER
C) You intend to collect blood samples from subjects to look for biomarkers or
pharmacogenetic information
Question 2
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
D) Single dose escalation study in hypertensive patients
CORRECT ANSWER
B) Single dose escalation PK study in healthy volunteers
1
,Question 3
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
CORRECT ANSWER
B) to FDA and investigators within 7 calendar days
Question 4
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
CORRECT ANSWER
D) Phase III pivotal study
Question 5
2
,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 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
CORRECT ANSWER
A) Request Special Protocol Assessment
Question 6
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
CORRECT ANSWER
B) Ensure content is sufficient to support meeting objective(s) and questions to FDA
Question 7
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. Which type of application will you prepare for
submission?
3
, A) 505 (b) (1)
B) 505 (b) (2)
C) 505 (j)
D) PMA
CORRECT ANSWER
B) 505 (b) (2)
Question 8
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
CORRECT ANSWER
A) Defer review of pending application(s)
Question 9
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
4
