Free Access RAPS.RAC-US.v2022-01-21.q33 Practice Test (Page 6)

Question 21

Which of the following BEST describes the purpose of the ICH?

A.To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions

B.To protect and promote public health through the evaluation and supervision of safe, effective, and high-quality medicines for the ICH regions

C.To provide scientific evaluation of applications for international marketing authorization for safe, effective, and high-quality medicines for the ICH regions

D.To lobby for improved industry standards for the development of new safe, effective, and high-quality medicines for the ICH regions

Question 22

During a routine review of promotional materials for a product, a regulatory affairs professional discovers an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory affairs professional to take?

A.Allow doctors to use the product for the off-label indication.

B.Request that doctors stop using the product for the off-label indication.

C.Communicate with the sales department to stop using the promotional materials.

D.Contact the marketing department to recall the product.

Question 23

During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic.
What should be done in response to identifying the impurity?

A.Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.

B.Perform both identification and non-clinical qualification studies concurrently.

C.Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.

D.Perform either an identification study or a non-clinical qualification study.

Question 24

Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?

A.Immunochemical and functional tests

B.Proposed dose and volume of administration

C.Biological activity with species and/or tissue specificity

D.Proposed product route and frequency of administration

Question 25

Which of the following statements regarding the off-label use of drugs is CORRECT?

A.The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby increasing access to much needed drugs and devices.

B.Sponsors are allowed to distribute publications about unapproved uses of approved drugs and devices as long as the marketing application is under review by the regulatory authority.

C.Although the regulatory authority reviews and approves drugs for specific indications, the approval does not limit the use of those drugs in clinical practice.

D.The regulatory authority does not restrict physician prescribing for off-label indications or regulate the manufacturer's promotion for such use.

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