Online Access Free RAPS.RAC-GS.v2022-04-07.q36 Practice Test (Page 5)

RAC-GS Exam Question 16

Which of the following is an example of an acceptable statement for an advertisement of an approved
arthritis medication?

A."Product X is safe for arthritis and without side effects."

B."Product X is effective in all patients with arthritis."

C."Product X is effective for the treatment of arthritis."

D."Product X is a guaranteed cure for arthritis."

RAC-GS Exam Question 17

Company X has a patent for an anti-inflammatory drug that will expire in one year. In order to minimize the
effect of the patent expiration, which is the BEST action for the company to take?

A.Conduct a Phase III study for a new unrelated indication of the drug.

B.Develop a generic version of the drug.

C.Develop a better brand-name drug in the same class.

D.Explore litigation strategy for patent infringements on the drug.

RAC-GS Exam Question 18

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

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

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

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

RAC-GS Exam Question 19

According to WHO, what are the temperature and humidity conditions for a Zone IVb long-term stability
study?

A.30c C and 65% RH

B.30 C and 35% RH

C.25: C and 60% RH

D.30: C and 75% RH

RAC-GS Exam Question 20

Which of the following statements regarding export regulations for an approved product is CORRECT?

A.The product must not be in conflict with the laws of the country to which it is intended for export.

B.The product must not be in accord with the specifications of the foreign purchaser.

C.The product must not be labeled on the outside of the shipping package that it is intended for export.

D.The product must not be sold or offered for sale in domestic commerce.

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RAC-GS Exam Question 16

RAC-GS Exam Question 17

RAC-GS Exam Question 18

RAC-GS Exam Question 19

RAC-GS Exam Question 20

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