RAC Practice Exam 1 questions with answers

RAC Practice Exam 1 questions with answers
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Which of the following is NOT required for compliance under 21
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CFR Part 11 (electronic records and electronic signatures)?
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A Manually generated timestamped audit trails to record the date
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and time of operator entries and actions that create, modify or
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delete electronic records. |\ |\




B Validation of systems to ensure accuracy
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C Authority checks to ensure that only authorized personell can
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create, modify or delete electronic records.
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D Establishment of and adherence to written procedures -
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CORRECT ANSWERS ✔✔A. |\ |\




The final authority for ensuring the adequacy of an
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Investigational New Drug (IND) informed consent document |\ |\ |\ |\ |\ |\ |\


resides with the: - CORRECT ANSWERS ✔✔Institutional Review
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Board (IRB) |\




A sponsor wishes to obtain permission from FDA to submit an
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ANDA for a drug product that varies from the Reference Listed
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Drug (RLD) in route of administration, dosage form, or strength,
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but anticipates that the labeling will be identical to that of the
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RLD. What process should be used to apply for that permission
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from FDA? - CORRECT ANSWERS ✔✔Suitability Petition
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A 505(b)(2) NDA is not an appropriate regulatory submission for
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the approval to market a - CORRECT ANSWERS ✔✔New chemical
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,entity when the sponsor has a right of reference to all applicable
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published studies |\




Distribution records for drug products must reference or contain: |\ |\ |\ |\ |\ |\ |\ |\


- CORRECT ANSWERS ✔✔Name and address of the consignee
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A mid-sized pharmaceutical company negotiated with FDA to
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submit a draft Package Insert (PI) and patient medication guide
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(MedGuide) in annotated Word format for initial FDA review, and |\ |\ |\ |\ |\ |\ |\ |\ |\ |\


committed to submit the Labeling in Structured Product Label |\ |\ |\ |\ |\ |\ |\ |\




(SPL) format upon approval of their product. What is the
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preferred timeline for this pharmaceutical company to submit the
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SPL formatted labeling upon product approval? - CORRECT
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ANSWERS ✔✔14 days |\ |\




Adverse event reporting for a marketed biologics product is NOT
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required for: - CORRECT ANSWERS ✔✔Diagnostic non-invasive
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test kits |\




The quality assurance manager of a small company consisting of
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12 employees is the only internal auditor for the company and
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has been performing all internal quality system audits for three
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years. This does not meet the requirements for performing
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internal quality systems audits because - CORRECT ANSWERS
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✔✔Auditor independence has not been ensured. |\ |\ |\ |\ |\




You have modified your 510(k)-cleared device with a Special
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510(k). In which case would a Special 510(k) not be appropriate
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for the device? - CORRECT ANSWERS ✔✔You have changed the
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primary mechanism of action. |\ |\ |\

, Which Premarket Approval Application (PMA) supplements are
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NOT subject to user fee exemption? - CORRECT ANSWERS
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✔✔Real Time Supplement |\ |\




A medical device company allows its sales force to maintain a
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product inventory in the field. The device has an expiration date
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indicated on its labeling. A sales person notes that one of his
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products has expired and contacts the headquarters office for
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direction. He is told to return the product to the headquarter
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office for replacement. The return of this product is considered as
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what type of recall? - CORRECT ANSWERS ✔✔Not a recall—it is
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considered normal stock rotation |\ |\ |\




A company is developing an (unapproved) drug-device
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combination product but is not sure to which center it should |\ |\ |\ |\ |\ |\ |\ |\ |\ |\ |\


submit its marketing application. The company should first
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submit - CORRECT ANSWERS ✔✔A Request for Designation to the
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Office of Combination Products
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A medical device company is developing a product with drug,
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biologic and device components. The product and indication have
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not been previously classified by FDA. What is the most
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appropriate regulatory pathway? - CORRECT ANSWERS ✔✔A |\ |\ |\ |\ |\ |\ |\


Request for Designation (RFD) should be sent to the Office of
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Combination Products (OCP) at FDA to determine the primary |\ |\ |\ |\ |\ |\ |\ |\ |\


mode of action (PMOA) and assign the agency with primary
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jurisdiction.