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RAC Practice Exam 1 2023 /Questions With Compete Solutions Rated (A+)
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RAC Practice Exam 1 2023 /Questions With CompeteSolutions Rated (A+)
Quiz :Which of the following is NOT required for compliance under 21 CFR Part
11 (electronic records and electronic signatures)?
A Manually generated timestamped audit trails to record the date and time of
operator entries and actions that create, modify or delete electronic records.
B Validation of systems to ensure accuracy
C Authority checks to ensure that only authorized personell can create, modify
or delete electronic records.
D Establishment of and adherence to written procedures -√Answer :A.
Quiz :The final authority for ensuring the adequacy of an Investigational New
Drug (IND) informed consent document resides with the: -
√Answer :Institutional Review Board (IRB)
Quiz :A sponsor wishes to obtain permission from FDA to submit an ANDA for a
drug product that varies from the Reference Listed Drug (RLD) in route of
administration, dosage form, or strength, but anticipates that the labeling will
be identical to that of the RLD. What process should be used to apply for that
permission from FDA? -√Answer :Suitability Petition
Quiz :A 505(b)(2) NDA is not an appropriate regulatory submission for the
approval to market a -√Answer :New chemical entity when the sponsor has a
right of reference to all applicable published studies
Quiz :Distribution records for drug products must reference or contain: -
√Answer :Name and address of the consignee
Quiz :A mid-sized pharmaceutical company negotiated with FDA to submit a
draft Package Insert (PI) and patient medication guide (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 preferred timeline for
this pharmaceutical company to submit the SPL formatted labeling upon
product approval? -√Answer :14 days
Quiz :Adverse event reporting for a marketed biologics product is NOT
required for: -√Answer :Diagnostic non-invasive test kits
,Quiz :The quality assurance manager of a small company consisting of 12
employees is the only internal auditor for the company and has been
performing all internal quality system audits for three years. This does not
meet the requirements for performing internal quality systems audits because
-√Answer :Auditor independence has not been ensured.
Quiz :You have modified your 510(k)-cleared device with a Special 510(k). In
which case would a Special 510(k) not be appropriate for the device? -√Answer
:You have changed the primary mechanism of action.
Quiz :Which Premarket Approval Application (PMA) supplements are NOT
subject to user fee exemption? -√Answer :Real Time Supplement
Quiz :A medical device company allows its sales force to maintain a product
inventory in the field. The device has an expiration date indicated on its
labeling. A sales person notes that one of his products has expired and
contacts the headquarters office for direction. He is told to return the product
to the headquarter office for replacement. The return of this product is
considered as what type of recall? -√Answer :Not a recall—it is considered
normal stock rotation
Quiz :A company is developing an (unapproved) drug-device combination
product but is not sure to which center it should submit its marketing
application. The company should first submit -√Answer :A Request for
Designation to the Office of Combination Products
Quiz :A medical device company is developing a product with drug, biologic
and device components. The product and indication have not been previously
classified by FDA. What is the most appropriate regulatory pathway? -
√Answer :A Request for Designation (RFD) should be sent to the Office of
Combination Products (OCP) at FDA to determine the primary mode of action
(PMOA) and assign the agency with primary jurisdiction.
Quiz :FDA's Office of Generic Drugs (OGD) remains committed to the "first-in,
first-reviewed" review order for the reviewing original Abbreviated New Drug
Applications (ANDAs), amendments and supplements unless there is a specific
reason to expedite an application. What is NOT a specific reason to grant
expedited review? -√Answer :Products that show evidence of safety and
effectiveness in a new subpopulation
, Quiz :A firm is preparing a 510(k), premarket notification to FDA for an in vitro
diagnostic test, a microhematocrit analyzer that, among other intended uses,
can determine the hematocrit of a blood donor prior to donation of a blood
product. The firm should address the 510(k) submission to: -√Answer :CBER
Quiz :Notice of Intent to Revoke license can be issued for the following reason,
EXCEPT
A Unable to gain access to the manufacturing plant,
B Licensed product are no longer safe and effective
C Failure to report serious adverse event,
D Manufacturer fails to conform to applicable standards -√Answer :C
Quiz :What is the formal early collaboration meeting that was implemented
through the Food and Drug Modernization Act (FDAMA)? -
√Answer :Agreement Meeting
The Agreement Meeting is a formal meeting to agree upon the parameters of
the investigational plan. When a meeting
request is received by FDA, the meeting will be held within 30 days. The
agreements made at the meeting are provided in writing to the sponsor and
are binding on FDA. Regulatory Reference: Early Collaboration Meetings Under
the FDA Modernization Act; Final Guidance for Industry and for CDRH Staff
(February 2001).
Quiz :A US medical device contract manufacturer has customers for whom it
manufactures medical device components (parts) and finished medical devices.
To date, all products have been either parts for Class II medical devices or Class
II finished medical devices. The manager of new business contacts the
regulatory manager to assess the impact of a possible new customer
involving a Class III device. What is the first question the regulatory manager
should ask in order to begin assessing the impact of Class III on plant
operations? -√Answer :Is it a component or device that would be
manufactured?
Quiz :The following biological products are regulated by CBER EXCEPT:
A Immunizing toxoids,
B Monoclonal antibodies for in vitro use,
C Monoclonal antibodies for in vivo use,
D Infusion of animal sourced cells into a hum -√Answer :B
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