US RAC Review Questions
RAPS Modules QUESTIONS
AND VERIFIED CORRECT
ANSWERS GRADED A+
[LATEST] 100% GUARANTEED
PASS
As a regulatory affairs professional, you are responsible for developing the content of an
information package for a Type B meeting with FDA. Your primary objective is to:
A) Reach consensus on content from contributing team members
B) Ensure content is sufficient to support meeting objective(s) and questions to FDA
C) Provide appropriate preclinical summary
D) Provide appropriate clinical summary - CORRECT ANSWER-B) Ensure content is sufficient to
support meeting objective(s) and questions to FDA
You, a regulatory affairs professional, are assessing the information to be submitted in support
of a marketing application for a new dosage form for a listed drug. You lack right of reference to
one key preclinical report. Which type of application will you prepare for submission?
A) 505 (b) (1)
B) 505 (b) (2)
C) 505 (j)
,D) PMA - CORRECT ANSWER-B) 505 (b) (2)
8) If FDA were to invoke the Application Integrity Policy, which of the following is a possible
outcome?
A) Defer review of pending application(s)
B) "File" a marketing application at the 60 day review
C) Grant a waiver or deferral for pediatric clinical study
D) Approve a marketing application - CORRECT ANSWER-A) Defer review of pending
application(s)
9) Which of the following supplements to an approved NDA/BLA must be approved by FDA prior
to distributing product made using the change?
A) Make change(s) to comply with USP
B) Change in the technical grade of an excipient, same
specifications and use
C) Add a warning statement to prescribing information
D) Process change outside the validated range - CORRECT ANSWER-D) Process change outside
the validated range
10) Which of the following products would not be regulated by CDER?
A) Therapeutic proteins
B) Vaccines
C) Chemically synthesized small molecules
D) Monoclonal antibodies - CORRECT ANSWER-B) Vaccines
, 11) Which of the following devices would be regulated by CBER?
A) Warming device
B) Blood pressure cuff
C) HIV diagnostic test kit
D) Capillary blood collection tube - CORRECT ANSWER-C) HIV diagnostic test kit
12) You are developing a combination product and believe the primary mode of action will
designate the product as a drug as opposed to a device. Your first course of action is to:
A) Develop written rationale describing the product, mode(s) of action, and proposed
classification as a drug
B) Submit a formal request for designation to the Office of Combination Products
C) Call the CDER review division
D) Check the FDA website for information, eg, other combination/similar products - CORRECT
ANSWER-D) Check the FDA website for information, eg, other combination/similar products
13) For a medical Device, what is NOT a responsibility of the US Agent for a Foreign
Establishment?
A) Report adverse events under the Medical Device Reporting regulation
B) Assisting FDA in communications with the foreign establishment,
C) Responding to questions concerning the foreign establishment's products that are imported
or offered for import into the United States, and
D) Assisting FDA in scheduling inspections of the foreign establishment. - CORRECT ANSWER-A)
Report adverse events under the Medical Device Reporting regulation
RAPS Modules QUESTIONS
AND VERIFIED CORRECT
ANSWERS GRADED A+
[LATEST] 100% GUARANTEED
PASS
As a regulatory affairs professional, you are responsible for developing the content of an
information package for a Type B meeting with FDA. Your primary objective is to:
A) Reach consensus on content from contributing team members
B) Ensure content is sufficient to support meeting objective(s) and questions to FDA
C) Provide appropriate preclinical summary
D) Provide appropriate clinical summary - CORRECT ANSWER-B) Ensure content is sufficient to
support meeting objective(s) and questions to FDA
You, a regulatory affairs professional, are assessing the information to be submitted in support
of a marketing application for a new dosage form for a listed drug. You lack right of reference to
one key preclinical report. Which type of application will you prepare for submission?
A) 505 (b) (1)
B) 505 (b) (2)
C) 505 (j)
,D) PMA - CORRECT ANSWER-B) 505 (b) (2)
8) If FDA were to invoke the Application Integrity Policy, which of the following is a possible
outcome?
A) Defer review of pending application(s)
B) "File" a marketing application at the 60 day review
C) Grant a waiver or deferral for pediatric clinical study
D) Approve a marketing application - CORRECT ANSWER-A) Defer review of pending
application(s)
9) Which of the following supplements to an approved NDA/BLA must be approved by FDA prior
to distributing product made using the change?
A) Make change(s) to comply with USP
B) Change in the technical grade of an excipient, same
specifications and use
C) Add a warning statement to prescribing information
D) Process change outside the validated range - CORRECT ANSWER-D) Process change outside
the validated range
10) Which of the following products would not be regulated by CDER?
A) Therapeutic proteins
B) Vaccines
C) Chemically synthesized small molecules
D) Monoclonal antibodies - CORRECT ANSWER-B) Vaccines
, 11) Which of the following devices would be regulated by CBER?
A) Warming device
B) Blood pressure cuff
C) HIV diagnostic test kit
D) Capillary blood collection tube - CORRECT ANSWER-C) HIV diagnostic test kit
12) You are developing a combination product and believe the primary mode of action will
designate the product as a drug as opposed to a device. Your first course of action is to:
A) Develop written rationale describing the product, mode(s) of action, and proposed
classification as a drug
B) Submit a formal request for designation to the Office of Combination Products
C) Call the CDER review division
D) Check the FDA website for information, eg, other combination/similar products - CORRECT
ANSWER-D) Check the FDA website for information, eg, other combination/similar products
13) For a medical Device, what is NOT a responsibility of the US Agent for a Foreign
Establishment?
A) Report adverse events under the Medical Device Reporting regulation
B) Assisting FDA in communications with the foreign establishment,
C) Responding to questions concerning the foreign establishment's products that are imported
or offered for import into the United States, and
D) Assisting FDA in scheduling inspections of the foreign establishment. - CORRECT ANSWER-A)
Report adverse events under the Medical Device Reporting regulation
