A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for review and approval. The regulatory authority issues the company a written commitment that if the studies are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and safety, the product will be approved.

During the final week of the review of the marketing application, which has fully met all pre- specified criteria, the company receives a letter from the regulatory authority stating that it no longer believes that

the product will be approved based on a recent withdrawal of a similar product in another country.

What is the BEST response?

A. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the application.

B. Consult with the legal department to discuss the best course of action.

C. Review the regulatory guidelines to determine how to proceed.

D. Request a meeting with the regulatory authority to discuss the application.

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.

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."

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

As a member of the product launch review committee, a regulatory affairs professional discovers a major issue with the labeling of a product prior to production. In addition to informing the committee, which is the BEST approach to address the issue?

A. Inform the regulatory authorities.

B. Delay the start of product production.

C. Correct the label text.

D. Abort the product launch.

A company establishes a new medical device indication for its consumer disposable products. The regulatory affairs professional is asked to give a 30-minute training session on these products to sales representatives. Which of the following subjects is the MOST important to discuss?

A. Labeling

B. Regulatory application summary

C. Risk management process

D. Safety-related reporting

A company is developing a new medical device. During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?

A. Concept development and validation

B. Concept development and early technical design

C. Early technical design and product release

D. Product release and validation

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. Proposed dose and volume of administration

B. Biological activity with species and/or tissue specificity

C. Immunochemical and functional tests

D. Proposed product route and frequency of administration

A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?

A. Plasma fractionation

B. Product distribution

C. Individual plasma donation

D. Plasma pooling

The manufacturer of an API was changed from Company X to Company Y during the late stage of a new drug development. Despite differences in the manufacturing processes of the companies, both APIs meet the current specifications. Which is the MOST appropriate information to include in the final submission documents?

A. The process information and analytical result of Company X API

B. The process information and analytical result of Company Y API

C. The process information and the comparative analytical result of APIs from both companies

D. Information deemed appropriate by the regulatory authority