RAC-USPDFで合格させるスゴ問題集でRAC-US最新のリアル試験問題 [Q23-Q46]

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RAC-USPDFで合格させるスゴ問題集でRAC-US最新のリアル試験問題

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新問題 23
A superiority advertising claim for a product versus its competitor’s product can only be made under which of the following circumstances?

In vitro studies show the product to be superior.

Government survey data indicate the product is superior.

Results of a three-year, post-market patient survey indicate the product is superior.

Results of adequate, well-controlled comparative clinical trial show the product is superior.

新問題 24
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?

Contact the regulatory authority to argue that its conclusions are wrong.

Contact the regulatory authority to discuss its findings.

Repeat the Hepatotoxicity tests and send the results to the regulatory authority.

Wait for the regulatory authority’s final publication on its findings.

新問題 25
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?

Potential clinical sites for the Phase III clinical trial

Regulatory requirements for labeling and packaging

Capacity of the manufacturing facilities to fully produce the new product

Previous actions taken by regulatory authorities on similar products

新問題 26
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?

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

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

Review the regulatory guidelines to determine how to proceed.

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

新問題 27
Which of the following statements regarding the off-label use of drugs is CORRECT?

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

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

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.

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

新問題 28
Which of the following is MOST appropriate for the purpose of lot release of biologics?

Inventory control

Safety assurance

Efficacy confirmation

Quality verification

新問題 29
A regulatory authority announces an inspection of a regulatory affairs professional’s facility during a holiday season when most of the staff Is not available. What is the MOST practical approach to this dilemma?

Negotiate with colleagues and the authority to find a better time.

Insist that key personnel be available for the inspection.

Inform the authority that the time is not suitable and request a new time

Arrange for an inspection without all intended personnel.

新問題 30
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?

Document any failure to follow regulatory compliance processes in employee performance reviews.

Develop documented procedures for regulatory compliance processes and train personnel.

Train all new employees on regulatory compliance processes and assign a mentor to them.

Train employees on all regulatory compliance processes using state-of-the-art systems.

新問題 31
In which section of the ICH Common Technical Document will the overview of clinical data appear?

Module 1

Module 2

Module 3

Module 4

新問題 32
According to WHO, what are the temperature and humidity conditions for a Zone IVb long- term stability study?

25: C and 60% RH

30 C and 35% RH

30c C and 65% RH

30: C and 75% RH

新問題 33
A company is preparing the submission package for a drug to be registered in international markets. When preparing the legal documentation, which document MUST comply with the
WHO recommendations?

Certificate of GMP

Certificate of Free Sale

Certificate of Pharmaceutical Product

Certificate of Analysis for the finished product

新問題 34
What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?

Safety and failure risk

Safety and effectiveness

Quality and failure risk

Quality and effectiveness

新問題 35
According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?

Class A

Class B

Class C

Class D

新問題 36
In a distribution contract for high-risk medical devices, which of the following regulatory requirements is the MOST important for the distributor?

Local reimbursement requirements

Service operation procedures

Training program for sales people

Written procedure for product traceability

新問題 37
Under which of the following circumstances would a regulatory authority require a more detailed premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data than would normally apply to an IVD device of that risk class?

The device is an updated version of a compliant device from the same manufacturer and contains no substantive change.

Internationally recognized standards are available to cover the main aspects of the device and have been used by the manufacturer.

The manufacturer’s experience level with the type of IVD medical device is limited.

The device incorporates well-established technology that is already present in the market.

新問題 38
Which term does NOT describe the same concept as the others?

Biosimilars

Follow-on protein products

Monoclonal antibody

Subsequent entry biologics

新問題 39
A company’s product was approved by a regulatory authority with the condition that further studies must be completed prior to full approval of the product.
To minimize product-associated risk to patients during the period of conditional approval, what is the LEAST effective way to achieve this goal?

Label the product for use in appropriate populations.

Educate patients and healthcare providers on how to use the product

Delay product launch until required studies are completed.

Promote off-label use to a carefully selected patient population.

新問題 40
A process is ultimately validated to ensure which of the following?

The process meets the regulatory requirements.

The process meets the quality system requirements.

The process consistently produces the desired results.

The process consistently meets the desired Quantity standards

新問題 41
GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation based on which of the following?

Instructions for use

Risk analysis

Product literature

Essential principles

新問題 42
A company is developing a new product for the global market. A new international guideline will recommend relevant studies in the pediatric population, and the guideline will be effective before the approval of the company’s new product.
What is the BEST advice the regulatory affairs professional can provide to minimize the impact of this guideline on the successful registration of the new product?

The company should consult with relevant regulatory authorities to determine the potential impact on the current registration plan.

The new guideline has no impact on the current registration plan, but the company must be prepared to defend its decision.

The new guideline has no impact on the current registration plan since all relevant registration studies are almost completed.

The company should initiate the required pediatric studies immediately to avoid costly delays to the current registration plan.

新問題 43
Which of the following is the MOST desirable timing and approach for a regulatory affairs professional who wants to provide feedback on proposed new regulations?

Before the enactment of the regulation, through the industry representative

Before the enactment of the regulation, through formal comments gathering process

After the enactment of the regulation, through the industry representative

After the enactment of the regulation, through a product-specific meeting

新問題 44
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?

Allow the auditor access to the room and records due to the current audit.

Allow the auditor accompanied access to the room to retrieve the records.

Deny the auditor access to the room and retrieve only the requested records.

Deny the auditor access to the room and records due to confidentiality concerns.

新問題 45
The intermediate manufacturing process was changed during development of a pharmaceutical. The change may impact the API specification. Which functional area is responsible for the final approval of the change?

Production

Analytical

Quality

Regulatory

新問題 46
Following the introduction of a new regulation, an evaluation of the company’s products by the regulatory affairs professional indicates that 60 percent do not comply with the regulation.
What should the regulatory affairs professional do FIRST to meet the new requirement?

Contact the trade association for advice.

Communicate with the relevant internal departments.

Prepare documents for the files.

Request a permanent waiver from the new regulation.