RAC CERTIFICATION EVALUATION 2026 FULL
QUESTIONS WITH SOLUTIONS
◉ 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
QUESTIONS WITH SOLUTIONS
◉ 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
