US RAC Review Questions RAPS Modules
2024 | 90 Questions with 100% Correct
Answers | Verified | Latest Update | Graded
A+
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 - ✔✔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 - ✔✔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 - ✔✔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 - ✔✔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 - ✔✔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 - ✔✔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
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