PRACTICE RAC EXAMINATION TEST 2026
QUESTIONS AND ANSWERS 100% PASS
GRADED A+
⩥ The final authority for ensuring the adequacy of an Investigational
New Drug (IND) informed consent document resides with the. Answer:
Institutional 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?. Answer: Suitability
Petition
⩥ 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
⩥ Distribution records for drug products must reference or contain:.
Answer: Name 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?. Answer: 14 days
⩥ Adverse event reporting for a marketed biologics product is NOT
required for:. Answer: Diagnostic 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. Answer: Auditor 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?.
Answer: You have changed the primary mechanism of action.
⩥ Which Premarket Approval Application (PMA) supplements are NOT
subject to user fee exemption?. Answer: Real 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?. Answer: Not 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. Answer: A 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?. 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.
⩥ 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
⩥ A firm is preparing a 510(k), premarket notification to FDA for an in
vitro diagnostic test, a microhematocrit analyzer that, among other
QUESTIONS AND ANSWERS 100% PASS
GRADED A+
⩥ The final authority for ensuring the adequacy of an Investigational
New Drug (IND) informed consent document resides with the. Answer:
Institutional 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?. Answer: Suitability
Petition
⩥ 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
⩥ Distribution records for drug products must reference or contain:.
Answer: Name 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?. Answer: 14 days
⩥ Adverse event reporting for a marketed biologics product is NOT
required for:. Answer: Diagnostic 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. Answer: Auditor 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?.
Answer: You have changed the primary mechanism of action.
⩥ Which Premarket Approval Application (PMA) supplements are NOT
subject to user fee exemption?. Answer: Real 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?. Answer: Not 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. Answer: A 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?. 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.
⩥ 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
⩥ A firm is preparing a 510(k), premarket notification to FDA for an in
vitro diagnostic test, a microhematocrit analyzer that, among other
