US RAC Review Questions RAPS Modules questions with answers

US RAC Review Questions RAPS Modules
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questions with answers |\ |\




In which situation is an IND not required?
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A) You intend to conduct a clinical trial with an investigational
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new drug|\




B) You intend to conduct a clinical trial with an approved drug to
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support a marketing application for a new indication
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C) You intend to collect blood samples from subjects to look for
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biomarkers or pharmacogenetic information |\ |\ |\




D) You intend to conduct a clinical trial using 2 of your approved
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drugs in a new combination - CORRECT ANSWERS ✔✔C) You
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intend to collect blood samples from subjects to look for
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biomarkers or pharmacogenetic information |\ |\ |\




In the clinical development plan for an investigational
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antihypertensive drug, which of the following studies would |\ |\ |\ |\ |\ |\ |\ |\


typically be conducted first:
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A) 1 month repeat dose toxicology study
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B) Single dose escalation PK study in healthy volunteers
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C) Multiple dose PK study in healthy volunteers
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D) Single dose escalation study in hypertensive patients -
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CORRECT ANSWERS ✔✔B) Single dose escalation PK study in
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healthy volunteers |\

,A sponsor must report an unexpected, fatal or life-threatening
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experience believed to be associated with an unapproved |\ |\ |\ |\ |\ |\ |\


drug/biologic:
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A) to FDA, investigators and IRBs within 7 calendar days
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B) to FDA and investigators within 7 calendar days
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C) to FDA within 14 calendar days
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D) to FDA and investigators within 7 working days - CORRECT
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ANSWERS ✔✔B) to FDA and investigators within 7 calendar days
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Which of the following is a covered study as defined under
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Financial Disclosure regulations: |\ |\




A) Phase I dose escalation study
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B) Phase I/II Pharmacokinetic Study
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C) A large open label safety study conducted at a large number
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of study sites
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D) Phase III pivotal study - CORRECT ANSWERS ✔✔D) Phase III
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pivotal study |\




Your company is developing a product to treat a serious and life
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threatening disease. A clinically meaningful, well established |\ |\ |\ |\ |\ |\ |\


primary endpoint will be used in the pivotal studies. Which
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regulatory strategy might you select prior to commencing Phase
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3 studies?
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,A) Request Special Protocol Assessment
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B) Request Fast Track Designation
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C) Request Priority Review
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D) Approval under Subpart H, Accelerated Approval of New Drugs
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for Serious or Life Threatening Illnesses - CORRECT ANSWERS
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✔✔A) Request Special Protocol Assessment
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As a regulatory affairs professional, you are responsible for
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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
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B) Ensure content is sufficient to support meeting objective(s)
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and questions to FDA
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C) Provide appropriate preclinical summary
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D) Provide appropriate clinical summary - CORRECT ANSWERS
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✔✔B) Ensure content is sufficient to support meeting objective(s)
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and questions to FDA
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You, a regulatory affairs professional, are assessing the
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information to be submitted in support of a marketing application |\ |\ |\ |\ |\ |\ |\ |\ |\


for a new dosage form for a listed drug. You lack right of
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reference to one key preclinical report. Which type of application
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will you prepare for submission?
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A) 505 (b) (1)
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B) 505 (b) (2)
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, C) 505 (j)
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D) PMA - CORRECT ANSWERS ✔✔B) 505 (b) (2)
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8) If FDA were to invoke the Application Integrity Policy, which of
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the following is a possible outcome?
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A) Defer review of pending application(s)
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B) "File" a marketing application at the 60 day review
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C) Grant a waiver or deferral for pediatric clinical study
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D) Approve a marketing application - CORRECT ANSWERS ✔✔A)
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Defer review of pending application(s)
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9) Which of the following supplements to an approved NDA/BLA
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must be approved by FDA prior to distributing product made
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using the change? |\ |\




A) Make change(s) to comply with USP
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B) Change in the technical grade of an excipient, same
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specifications and use |\ |\




C) Add a warning statement to prescribing information
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D) Process change outside the validated range - CORRECT
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ANSWERS ✔✔D) Process change outside the validated range
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10) Which of the following products would not be regulated by
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CDER?