RAC PRACTICE EXAM 1 2024. 100 TOP RATED QUESTIONS. PASSING
GUARANTEED 100%
1. 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:
2. The final authority for ensuring the adequacy of an Investigational New Drug (IND)
informed consent document resides with the:: Institutional Review Board (IRB)
3. 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?:
Suitability Petition
4. A 505(b)(2) NDA is not an appropriate regulatory submission for the ap- proval to
market a: New chemical entity when the sponsor has a right of reference to all applicable
published studies
5. Distribution records for drug products must reference or contain:: Name and address
of the consignee
6. 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?: 14
days
7. Adverse event reporting for a marketed biologics product is NOT required for::
Diagnostic non-invasive test kits
8. The quality assurance manager of a small company consisting of 12 em- ployees 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: Auditor independence has not been ensured.
9. 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?: You have changed the primary
mechanism of action.
,10. Which Premarket Approval Application (PMA) supplements are NOT sub- ject to user
fee exemption?: Real Time Supplement
11. 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 label- ing. 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?: Not a recall—it is considered normal stock
rotation
12. A company is developing an (unapproved) drug-device combination prod- uct but is
not sure to which center it should submit its marketing application. The company should
first submit: A Request for Designation to the Office of Combination Products
13. A medical device company is developing a product with drug, biologic and device
components. The product and indication have not been previously clas- sified by FDA. What
is the most appropriate regulatory pathway?: 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.
14. 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 spe- cific reason to expedite an
application. What is NOT a specific reason to grant expedited review?: Products that show
evidence of safety and effectiveness in a new subpopulation
15. 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:: CBER
16. 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:
17. What is the formal early collaboration meeting that was implemented through the
Food and Drug Modernization Act (FDAMA)?: 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).
18. A US medical device contract manufacturer has customers for whom it manufactures
medical device components (parts) and finished medical de- vices. 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?: Is it a component or device that would be manufactured?
19. 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:
20. You work for a company that is developing an autologous cellular therapy product.
FDA has informed your company that your product will be regulated as a HCT/P (Human
Cells, Tissues and Cellular and Tissue-Based Product). Based on this information, which of
the following regulatory requirements will your company need to be compliant with when
manufacturing
the product?: All Subparts of 21 CFR 1271 except Subpart C (Donor Eligibility)
21. A company has submitted its NDA for review. An NDA amendment can be submitted
to change or add information to a not yet-
approved NDA. When must new safety information be submitted in a safety update
report?: Four months after the initial NDA submission (120 day safety update)
22. A television advertisement that you have been asked to review prior to release
discusses the benefits of the drug in detail for 25 seconds, and then names all the major
side effects associated with the product in the last five seconds.You should advise that::
The benefits and side effects of the drug should be presented with the same level of scope,
depth and detail.
23. At the completion of a Preapproval Inspection where a deficiency was noted, a
meeting is convened to discuss what document?: Form FDA 483
24. Due to market interest, a new strength for an existing combination OTC product for
use in the adult population (labeled as 12 years of age and older) has been developed, and
appropriate data have been gathered to support safety and efficacy. The existing product is
regulated by a final monograph, but does not contain labeling for use of the new strength
in adult populations.
GUARANTEED 100%
1. 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:
2. The final authority for ensuring the adequacy of an Investigational New Drug (IND)
informed consent document resides with the:: Institutional Review Board (IRB)
3. 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?:
Suitability Petition
4. A 505(b)(2) NDA is not an appropriate regulatory submission for the ap- proval to
market a: New chemical entity when the sponsor has a right of reference to all applicable
published studies
5. Distribution records for drug products must reference or contain:: Name and address
of the consignee
6. 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?: 14
days
7. Adverse event reporting for a marketed biologics product is NOT required for::
Diagnostic non-invasive test kits
8. The quality assurance manager of a small company consisting of 12 em- ployees 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: Auditor independence has not been ensured.
9. 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?: You have changed the primary
mechanism of action.
,10. Which Premarket Approval Application (PMA) supplements are NOT sub- ject to user
fee exemption?: Real Time Supplement
11. 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 label- ing. 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?: Not a recall—it is considered normal stock
rotation
12. A company is developing an (unapproved) drug-device combination prod- uct but is
not sure to which center it should submit its marketing application. The company should
first submit: A Request for Designation to the Office of Combination Products
13. A medical device company is developing a product with drug, biologic and device
components. The product and indication have not been previously clas- sified by FDA. What
is the most appropriate regulatory pathway?: 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.
14. 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 spe- cific reason to expedite an
application. What is NOT a specific reason to grant expedited review?: Products that show
evidence of safety and effectiveness in a new subpopulation
15. 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:: CBER
16. 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:
17. What is the formal early collaboration meeting that was implemented through the
Food and Drug Modernization Act (FDAMA)?: 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).
18. A US medical device contract manufacturer has customers for whom it manufactures
medical device components (parts) and finished medical de- vices. 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?: Is it a component or device that would be manufactured?
19. 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:
20. You work for a company that is developing an autologous cellular therapy product.
FDA has informed your company that your product will be regulated as a HCT/P (Human
Cells, Tissues and Cellular and Tissue-Based Product). Based on this information, which of
the following regulatory requirements will your company need to be compliant with when
manufacturing
the product?: All Subparts of 21 CFR 1271 except Subpart C (Donor Eligibility)
21. A company has submitted its NDA for review. An NDA amendment can be submitted
to change or add information to a not yet-
approved NDA. When must new safety information be submitted in a safety update
report?: Four months after the initial NDA submission (120 day safety update)
22. A television advertisement that you have been asked to review prior to release
discusses the benefits of the drug in detail for 25 seconds, and then names all the major
side effects associated with the product in the last five seconds.You should advise that::
The benefits and side effects of the drug should be presented with the same level of scope,
depth and detail.
23. At the completion of a Preapproval Inspection where a deficiency was noted, a
meeting is convened to discuss what document?: Form FDA 483
24. Due to market interest, a new strength for an existing combination OTC product for
use in the adult population (labeled as 12 years of age and older) has been developed, and
appropriate data have been gathered to support safety and efficacy. The existing product is
regulated by a final monograph, but does not contain labeling for use of the new strength
in adult populations.
