1|Page
US RAC Review Questions RAPS Modules Exam ,
Most Recent||Verified Exam!! || 2026 Actual Complete
Real Exam Questions With verified Answers (Correct
Answers) Already Graded A+ ,Guaranteed success|
Newest Exam!!!
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 -
Answers-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:
,2|Page
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 - Answers-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. Which
type of application will you prepare for submission?
A) 505 (b) (1)
B) 505 (b) (2)
C) 505 (j)
D) PMA - Answers-B) 505 (b) (2)
In which situation is an IND not required?
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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 - Answers-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
D) Single dose escalation study in hypertensive patients -
Answers-B) Single dose escalation PK study in healthy
volunteers
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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 -
Answers-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 - Answers-D) Phase III pivotal
study
US RAC Review Questions RAPS Modules Exam ,
Most Recent||Verified Exam!! || 2026 Actual Complete
Real Exam Questions With verified Answers (Correct
Answers) Already Graded A+ ,Guaranteed success|
Newest Exam!!!
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 -
Answers-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:
,2|Page
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 - Answers-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. Which
type of application will you prepare for submission?
A) 505 (b) (1)
B) 505 (b) (2)
C) 505 (j)
D) PMA - Answers-B) 505 (b) (2)
In which situation is an IND not required?
,3|Page
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 - Answers-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
D) Single dose escalation study in hypertensive patients -
Answers-B) Single dose escalation PK study in healthy
volunteers
, 4|Page
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 -
Answers-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 - Answers-D) Phase III pivotal
study
