RAC PRACTICE EXAM 1 / ACTUAL TEST
QUESTIONS WITH DETAILED VERIFIED ANSWERS
/ ALREADY GRADED A
Save
Terms in this set (93)
Which of the following is NOT A.
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
The final authority for ensuring the Institutional Review Board (IRB)
adequacy of an Investigational New
Drug (IND) informed consent
document resides with the:
,A sponsor wishes to obtain Suitability Petition
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?
A 505(b)(2) NDA is not an New chemical entity when the sponsor has a right
appropriate regulatory submission of reference to all applicable published studies
for the approval to market a
Distribution records for drug Name and address of the consignee
products must reference or contain:
A mid-sized pharmaceutical 14 days
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?
,Adverse event reporting for a Diagnostic non-invasive test kits
marketed biologics product is NOT
required for:
The quality assurance manager of a Auditor independence has not been ensured.
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
You have modified your 510(k)- You have changed the primary mechanism of
cleared device with a Special 510(k). action.
In which case would a Special 510(k)
not be appropriate for the device?
Which Premarket Approval Real Time Supplement
Application (PMA) supplements are
NOT subject to user fee exemption?
A medical device company allows its Not a recall—it is considered normal stock rotation
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?
, A company is developing an A Request for Designation to the Office of
(unapproved) drug-device Combination Products
combination product but is not sure
to which center it should submit its
marketing application. The company
should first submit
A medical device company is A Request for Designation (RFD) should be sent to
developing a product with drug, the Office of Combination Products (OCP) at FDA
biologic and device components. to determine the primary mode of action (PMOA)
The product and indication have not and assign the agency with primary jurisdiction.
been previously classified by FDA.
What is the most appropriate
regulatory pathway?
FDA's Office of Generic Drugs (OGD) Products that show evidence of safety and
remains committed to the "first-in, effectiveness in a new subpopulation
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?
A firm is preparing a 510(k), CBER
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:
QUESTIONS WITH DETAILED VERIFIED ANSWERS
/ ALREADY GRADED A
Save
Terms in this set (93)
Which of the following is NOT A.
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
The final authority for ensuring the Institutional Review Board (IRB)
adequacy of an Investigational New
Drug (IND) informed consent
document resides with the:
,A sponsor wishes to obtain Suitability Petition
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?
A 505(b)(2) NDA is not an New chemical entity when the sponsor has a right
appropriate regulatory submission of reference to all applicable published studies
for the approval to market a
Distribution records for drug Name and address of the consignee
products must reference or contain:
A mid-sized pharmaceutical 14 days
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?
,Adverse event reporting for a Diagnostic non-invasive test kits
marketed biologics product is NOT
required for:
The quality assurance manager of a Auditor independence has not been ensured.
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
You have modified your 510(k)- You have changed the primary mechanism of
cleared device with a Special 510(k). action.
In which case would a Special 510(k)
not be appropriate for the device?
Which Premarket Approval Real Time Supplement
Application (PMA) supplements are
NOT subject to user fee exemption?
A medical device company allows its Not a recall—it is considered normal stock rotation
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?
, A company is developing an A Request for Designation to the Office of
(unapproved) drug-device Combination Products
combination product but is not sure
to which center it should submit its
marketing application. The company
should first submit
A medical device company is A Request for Designation (RFD) should be sent to
developing a product with drug, the Office of Combination Products (OCP) at FDA
biologic and device components. to determine the primary mode of action (PMOA)
The product and indication have not and assign the agency with primary jurisdiction.
been previously classified by FDA.
What is the most appropriate
regulatory pathway?
FDA's Office of Generic Drugs (OGD) Products that show evidence of safety and
remains committed to the "first-in, effectiveness in a new subpopulation
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?
A firm is preparing a 510(k), CBER
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:
