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US RAC Review Questions RAPS Modules with correct Answers
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US RAC Review Questions RAPS Modules with correct Answers
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US RAC Review Questions RAPSModules with correct Answers
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 - 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
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
,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:
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)
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 - Answers -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
C) Add a warning statement to prescribing information
, D) Process change outside the validated range - Answers -D) Process change outside
the validated range
10) Which of the following products would not be regulated by CDER?
A) Therapeutic proteins
B) Vaccines
C) Chemically synthesized small molecules
D) Monoclonal antibodies - Answers -B) Vaccines
11) Which of the following devices would be regulated by CBER?
A) Warming device
B) Blood pressure cuff
C) HIV diagnostic test kit
D) Capillary blood collection tube - Answers -C) HIV diagnostic test kit
12) You are developing a combination product and believe the primary mode of action
will designate the product as a drug as opposed to a device. Your first course of action
is to:
A) Develop written rationale describing the product, mode(s) of action, and proposed
classification as a drug
B) Submit a formal request for designation to the Office of Combination Products
C) Call the CDER review division
D) Check the FDA website for information, eg, other combination/similar products -
Answers -D) Check the FDA website for information, eg, other combination/similar
products
13) For a medical Device, what is NOT a responsibility of the US Agent for a Foreign
Establishment?
A) Report adverse events under the Medical Device Reporting regulation
B) Assisting FDA in communications with the foreign establishment,
C) Responding to questions concerning the foreign establishment's products that are
imported or offered for import into the United States, and
D) Assisting FDA in scheduling inspections of the foreign establishment. - Answers -A)
Report adverse events under the Medical Device Reporting regulation
14) Which Congressional Act provided Statutory Authority to FDA to regulate medical
devices?
A) Safe Medical Devices Act of 1990 (SMDA)
B) Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
C) Federal Food, Drug, Cosmetic Act (FDC Act)
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