US RAC REVIEW QUESTIONS RAPS
MODULES & ACCURATE SOLUTIONS
RATED 100% CORRECT
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
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
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
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
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
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
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 - correct answer ✔✔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 - correct answer ✔✔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
MODULES & ACCURATE SOLUTIONS
RATED 100% CORRECT
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
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
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
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
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
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
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 - correct answer ✔✔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 - correct answer ✔✔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
