RAPS RAC-GS Online Practice Questions and Exam Preparation

RAPS RAC-GS Online Questions & Answers

• Question 81:

  One month prior to the anticipated approval date for your product, the marketing application that you submitted to a major regulatory authority has become the subject of an advisory committee meeting of experts convened by the regulatory authority. The advisory committee members unanimously vote not to approve your product because of a safety concern. Two days after the advisory committee meeting, the regulatory authority requests additional information to support the safety of your product. Assuming you have no additional data to provide, which of the following would be your MOST appropriate response to the regulatory authority's request?

  A. "Given the advisory committee's unanimous decision, we know that the product will not be approved, and additional data will not make any difference."
  B. "We have no additional informationto provide at this time, but wecan perform an additional analysis for a specific safety concern, if necessary."
  C. "We disagree with the advisory committee's decision because the committee neglected the thorough safety analysis that we provided."
  D. "We have no additional information to provide at this time because we have already provided everything needed to support our product's approval."
  B. "We have no additional informationto provide at this time, but wecan perform an additional analysis for a specific safety concern, if necessary."

• Question 82:

  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 either an identification study or a non-clinical qualification study.
  B. Perform both identification and non-clinical qualification studies concurrently.
  C. Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.
  D. Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.
  C. Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.

• Question 83:

  In preparation for the development of a new line of products, a regulatory affairs professional is asked to prepare a short presentation for senior management. Which of the following topics is MOST important to cover?

  A. Potential clinical sites for the Phase III clinical trial
  B. Regulatory requirements for labeling and packaging
  C. Capacity of the manufacturing facilities to fully produce the new product
  D. Previous actions taken by regulatory authorities on similar products
  D. Previous actions taken by regulatory authorities on similar products

• Question 84:

  A drug product presents degradation during the manufacturing process. In addition to the amount, what information should be provided FIRST in order to use API overage?

  A. Specification
  B. Formulation
  C. Property
  D. Justification
  D. Justification

• Question 85:

  After numerous failed attempts to decrease an identified risk in a medical device to an acceptable level, the medical device continues to have unacceptable risks. However, the development team wants to continue development. Which is the BEST recommendation to make in this situation?

  A. Add a warning in the IFU.
  B. Discontinue the project.
  C. Perform another risk-benefit analysis.
  D. Redesign the device.
  D. Redesign the device.

• Question 86:

  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. Approved indications of the drug
  B. Determination of primary mode of action
  C. Determination of product design deliverables
  D. Guidance documents for the device
  C. Determination of product design deliverables

• Question 87:

  During routine surveillance, a regulatory authority sent a company the following communication: "Hepatotoxicity and suicidal behavior were identified as potential safety issues for the company's product. The regulatory authority is evaluating these issues to determine the need for any regulatory action." Which action would be the most appropriate FIRST step for the company to take?

  A. Contact the regulatory authority to argue that its conclusions are wrong.
  B. Contact the regulatory authority to discuss its findings.
  C. Repeat the Hepatotoxicity tests and send the results to the regulatory authority.
  D. Wait for the regulatory authority's final publication on its findings.
  B. Contact the regulatory authority to discuss its findings.

• Question 88:

  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 Company X that it has no right to send such a letter and do nothing further.
  D. Inform the local regulatory authority of the letter and discuss how to respond.
  B. Inform the legal department of the letter and discuss how to respond.
  D. Inform the local regulatory authority of the letter and discuss how to respond.

• Question 89:

  During an audit of a contract manufacturing facility by a potential client, the auditor requested to be left alone in the records room. The records room contains information on all products produced by the contract manufacturer. Which action is MOST appropriate for the regulatory affairs professional to take?

  A. Allow the auditor access to the room and records due to the current audit.
  B. Allow the auditor accompanied access to the room to retrieve the records.
  C. Deny the auditor access to the room and retrieve only the requested records.
  D. Deny the auditor access to the room and records due to confidentiality concerns.
  B. Allow the auditor accompanied access to the room to retrieve the records.

• Question 90:

  A global company has obtained a patent in a specific country for a newly marketed product. What would be the BEST advice In order to protect the patent in other countries?

  A. Use the Madrid system.
  B. Use the community patent system.
  C. File patents of interest in target countries.
  D. File design patents in target countries.
  C. File patents of interest in target countries.