US RAC Practice Exam Latest Questions and Answers|
Verified Answers
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 - ANSWERA.
The final authority for ensuring the adequacy of an Investigational New Drug (IND)
informed consent document resides with the: - ANSWERInstitutional Review Board
(IRB)
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? -
ANSWERSuitability Petition
A 505(b)(2) NDA is not an appropriate regulatory submission for the approval to
market a - ANSWERNew chemical entity when the sponsor has a right of reference to
all applicable published studies
Distribution records for drug products must reference or contain: - ANSWERName
and address of the consignee
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? - ANSWER14 days
Adverse event reporting for a marketed biologics product is NOT required for: -
ANSWERDiagnostic non-invasive test kits
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 - ANSWERAuditor independence has not
been ensured.
, 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? - ANSWERYou have
changed the primary mechanism of action.
Which Premarket Approval Application (PMA) supplements are NOT subject to user
fee exemption? - ANSWERReal Time Supplement
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? - ANSWERNot a recall
—it is considered normal stock rotation
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 - ANSWERA Request for Designation to the Office of Combination
Products
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? - ANSWERA 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.
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? - ANSWERProducts that show evidence of safety and effectiveness in a new
subpopulation
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: - ANSWERCBER
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 - ANSWERC
What is the formal early collaboration meeting that was implemented through the
Food and Drug Modernization Act (FDAMA)? - ANSWERAgreement Meeting
Verified Answers
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 - ANSWERA.
The final authority for ensuring the adequacy of an Investigational New Drug (IND)
informed consent document resides with the: - ANSWERInstitutional Review Board
(IRB)
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? -
ANSWERSuitability Petition
A 505(b)(2) NDA is not an appropriate regulatory submission for the approval to
market a - ANSWERNew chemical entity when the sponsor has a right of reference to
all applicable published studies
Distribution records for drug products must reference or contain: - ANSWERName
and address of the consignee
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? - ANSWER14 days
Adverse event reporting for a marketed biologics product is NOT required for: -
ANSWERDiagnostic non-invasive test kits
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 - ANSWERAuditor independence has not
been ensured.
, 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? - ANSWERYou have
changed the primary mechanism of action.
Which Premarket Approval Application (PMA) supplements are NOT subject to user
fee exemption? - ANSWERReal Time Supplement
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? - ANSWERNot a recall
—it is considered normal stock rotation
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 - ANSWERA Request for Designation to the Office of Combination
Products
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? - ANSWERA 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.
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? - ANSWERProducts that show evidence of safety and effectiveness in a new
subpopulation
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: - ANSWERCBER
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 - ANSWERC
What is the formal early collaboration meeting that was implemented through the
Food and Drug Modernization Act (FDAMA)? - ANSWERAgreement Meeting
