US RAC Review Questions RAPS Modules Exam Questions and
Answers with Verified Solutions | Latest 2026 Update
Q: In which situation is an IND not required?
You intend to conduct a clinical trial with an investigational new drug
You intend to conduct a clinical trial with an approved drug to support a marketing
application for a new indication
You intend to collect blood samples from subjects to look for biomarkers or
pharmacogenetic information
You intend to conduct a clinical trial using 2 of your approved drugs in a new
combination
Answer:
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:
1 month repeat dose toxicology study
Single dose escalation PK study in healthy volunteers
Multiple dose PK study in healthy volunteers
Q: Single dose escalation study in hypertensive patients
Answer:
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:
to FDA, investigators and IRBs within 7 calendar days
to FDA and investigators within 7 calendar days
to FDA within 14 calendar days
Q: to FDA and investigators within 7 working days
Answer:
B) to FDA and investigators within 7 calendar days
Which of the following is a covered study as defined under Financial Disclosure
regulations:
0 0 Phase I dose escalation study
,Phase I/II Pharmacokinetic Study
A large open label safety study conducted at a large number of study sites
Q: Phase III pivotal study
Answer:
D) Phase III pivotal study
Q: 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?
Request Special Protocol Assessment
Request Fast Track Designation
Request Priority Review
Approval under Subpart H, Accelerated Approval of New Drugs for Serious or
Life Threatening Illnesses
Answer:
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:
Reach consensus on content from contributing team members
Ensure content is sufficient to support meeting objective(s) and questions to FDA
Provide appropriate preclinical summary
Q: Provide appropriate clinical summary
Answer:
B) Ensure content is sufficient to support meeting objective(s) and questions to
FDA
Q: 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?
505 (b) (1)
505 (b) (2)
, 0 0 505 (j)
PMA
Answer:
B) 505 (b) (2)
Q: If FDA were to invoke the Application Integrity Policy, which of the
following is a possible outcome?
Defer review of pending application(s)
"File" a marketing application at the 60 day review
Grant a waiver or deferral for pediatric clinical study
Approve a marketing application
Answer:
A) Defer review of pending application(s)
Q: Which of the following supplements to an approved NDA/BLA must be
approved by FDA prior to distributing product made using the change?
Make change(s) to comply with USP
Change in the technical grade of an excipient, same specifications and use
Add a warning statement to prescribing information
Process change outside the validated range
Answer:
D) Process change outside the validated range
Q: Which of the following products would not be regulated by CDER?
Therapeutic proteins
Vaccines
Chemically synthesized small molecules
Monoclonal antibodies
Answer:
B) Vaccines
Q: Which of the following devices would be regulated by CBER?
Warming device
0 0 Blood pressure cuff
HIV diagnostic test kit
Capillary blood collection tube
Answers with Verified Solutions | Latest 2026 Update
Q: In which situation is an IND not required?
You intend to conduct a clinical trial with an investigational new drug
You intend to conduct a clinical trial with an approved drug to support a marketing
application for a new indication
You intend to collect blood samples from subjects to look for biomarkers or
pharmacogenetic information
You intend to conduct a clinical trial using 2 of your approved drugs in a new
combination
Answer:
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:
1 month repeat dose toxicology study
Single dose escalation PK study in healthy volunteers
Multiple dose PK study in healthy volunteers
Q: Single dose escalation study in hypertensive patients
Answer:
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:
to FDA, investigators and IRBs within 7 calendar days
to FDA and investigators within 7 calendar days
to FDA within 14 calendar days
Q: to FDA and investigators within 7 working days
Answer:
B) to FDA and investigators within 7 calendar days
Which of the following is a covered study as defined under Financial Disclosure
regulations:
0 0 Phase I dose escalation study
,Phase I/II Pharmacokinetic Study
A large open label safety study conducted at a large number of study sites
Q: Phase III pivotal study
Answer:
D) Phase III pivotal study
Q: 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?
Request Special Protocol Assessment
Request Fast Track Designation
Request Priority Review
Approval under Subpart H, Accelerated Approval of New Drugs for Serious or
Life Threatening Illnesses
Answer:
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:
Reach consensus on content from contributing team members
Ensure content is sufficient to support meeting objective(s) and questions to FDA
Provide appropriate preclinical summary
Q: Provide appropriate clinical summary
Answer:
B) Ensure content is sufficient to support meeting objective(s) and questions to
FDA
Q: 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?
505 (b) (1)
505 (b) (2)
, 0 0 505 (j)
PMA
Answer:
B) 505 (b) (2)
Q: If FDA were to invoke the Application Integrity Policy, which of the
following is a possible outcome?
Defer review of pending application(s)
"File" a marketing application at the 60 day review
Grant a waiver or deferral for pediatric clinical study
Approve a marketing application
Answer:
A) Defer review of pending application(s)
Q: Which of the following supplements to an approved NDA/BLA must be
approved by FDA prior to distributing product made using the change?
Make change(s) to comply with USP
Change in the technical grade of an excipient, same specifications and use
Add a warning statement to prescribing information
Process change outside the validated range
Answer:
D) Process change outside the validated range
Q: Which of the following products would not be regulated by CDER?
Therapeutic proteins
Vaccines
Chemically synthesized small molecules
Monoclonal antibodies
Answer:
B) Vaccines
Q: Which of the following devices would be regulated by CBER?
Warming device
0 0 Blood pressure cuff
HIV diagnostic test kit
Capillary blood collection tube
