Free Access RAPS.RAC-US.v2022-06-05.q36 Practice Test (Page 7)

Question 26

A materials supplier informs a company that it intends to stop supplying a material critical to the manufacture of the company's products. What action should the company take FIRST?

A.Review the company's existing Quality Management System

B.Complete a gap analysis to identify options.

C.Qualify another supplier and execute a supplier agreement.

D.Reformulate the products with a replacement material.

Question 27

At a recent scientific meeting, Company Y had two booths:
* At one booth, Company Y provided brochures on a completed Phase II study.
* In an adjacent booth, Company Y's sales professionals were promoting one of Company
Y's marketed products.
A regulatory affairs-professional at Company X sends a letter to a counterpart at Company
Y requesting that Company Y stop this practice in the future and demanding a formal response to the letter. How should the regulatory affairs professional at Company Y BEST respond?

A.Inform the local regulatory authority of the letter and discuss how to respond.

B.Acknowledge receipt of the letter in a written response but do nothing further.

C.Inform Company X that it has no right to send such a letter and do nothing further.

D.Inform the legal department of the letter and discuss how to respond.

Question 28

Which of the following claims would classify an apple as a drug?

A."It will satisfy hunger."

B."It will prevent colds."

C."It will make you look younger."

D."It will whiten teeth."

Question 29

A company is developing a new line of products in an area that is new to the company.
What is the BEST approach?

A.Obtain competitor research and provide the information to the management team.

B.Summarize regulatory documents and history and provide the information to the management team.

C.Ask the trade association representative to provide an overview of the new product area to the marketing team.

D.Obtain regulatory documents and history and provide the information to R&D.

Question 30

A company is developing a device-drug combination product. Which of the following should be evaluated FIRST in order to determine the applicable guidance documents?

A.Determination of product design deliverables

B.Determination of primary mode of action

C.Approved indications of the drug

D.Guidance documents for the device

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