RAC Practice Exam 1
QUESTIONS AND VERIFIED
CORRECT ANSWERS
GRADED A+ [LATEST] 100%
GUARANTEED PASS
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? - CORRECT 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 -
CORRECT 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? - CORRECT 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? - CORRECT 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 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: - CORRECT ANSWER-CBER
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 - CORRECT ANSWER-C
What is the formal early collaboration meeting that was implemented through the Food and
Drug Modernization Act (FDAMA)? - CORRECT ANSWER-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).
A US medical device contract manufacturer has customers for whom it manufactures medical
device components (parts) and finished medical devices. 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? - CORRECT ANSWER-Is it a
component or device that would be manufactured?
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 - CORRECT ANSWER-B
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? - CORRECT ANSWER-All Subparts of 21 CFR 1271 except Subpart C (Donor
Eligibility)
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? -
CORRECT ANSWER-Four months after the initial NDA submission (120 day safety update)
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: - CORRECT
ANSWER-The benefits and side effects of the drug should be presented with the same level of
scope, depth and detail.
At the completion of a Preapproval Inspection where a deficiency was noted, a meeting is
convened to discuss what document? - CORRECT ANSWER-Form FDA 483
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.
What options could the company utilize to modify the monograph in order to gain FDA approval
QUESTIONS AND VERIFIED
CORRECT ANSWERS
GRADED A+ [LATEST] 100%
GUARANTEED PASS
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? - CORRECT 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 -
CORRECT 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? - CORRECT 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? - CORRECT 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 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: - CORRECT ANSWER-CBER
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 - CORRECT ANSWER-C
What is the formal early collaboration meeting that was implemented through the Food and
Drug Modernization Act (FDAMA)? - CORRECT ANSWER-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).
A US medical device contract manufacturer has customers for whom it manufactures medical
device components (parts) and finished medical devices. 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? - CORRECT ANSWER-Is it a
component or device that would be manufactured?
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 - CORRECT ANSWER-B
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? - CORRECT ANSWER-All Subparts of 21 CFR 1271 except Subpart C (Donor
Eligibility)
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? -
CORRECT ANSWER-Four months after the initial NDA submission (120 day safety update)
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: - CORRECT
ANSWER-The benefits and side effects of the drug should be presented with the same level of
scope, depth and detail.
At the completion of a Preapproval Inspection where a deficiency was noted, a meeting is
convened to discuss what document? - CORRECT ANSWER-Form FDA 483
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.
What options could the company utilize to modify the monograph in order to gain FDA approval
