RAC-US Online Practice Questions and Answers

Company X acquires Company Y. Both companies produce pharmaceuticals distributed globally. A regulatory authority requires that all labeling for Company Y's products be converted to Company X within three months. The regulatory affairs professional at Company X concludes that it is not feasible to meet this request within the time frame.

Which is the FIRST step that the regulatory affairs professional at Company X should take to address the situation?

A. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period from the regulatory authority.

B. Request additional resources from senior management in order to complete the labeling conversion within the time frame given by the regulatory authority.

C. Submit as many labelingconversion applications as possible within the time frame and request an extension for the remaining ones.

D. Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority requirement and assign responsibilities.

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?

A. Certificate of GMP

B. Certificate of Free Sale

C. Certificate of Pharmaceutical Product

D. Certificate of Analysis for the finished product

A company is developing a new line of products in an area that is new to the company. What is the BEST approach?

A. Ask the trade association representative to provide an overview of the new product area to the marketing team.

B. Obtain competitor research and provide the information to the management team.

C. Obtain regulatory documents and history and provide the information to RandD.

D. Summarize regulatory documents and history and provide the information to the management team.

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?

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

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

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

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

Which of the following is NOT required to be included in a marketing application?

A. Final printed label

B. Quality, safety, and efficacy Information

C. Administrative forms

D. Evidence of fee payment

A clinical study of a drug is completed to support a marketing approval application. According to ICH,how long should a sponsor retain the clinical study essential documents?

A. For at least two years after the last approval of an application in an ICH region

B. Fora minimum of 10 years after completion of the clinical study

C. Three years after the last clinical study site was supplied with investigational drugs

D. Until the product has been discontinued from marketing in all ICH regions

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

A. In vitro studies show the product to be superior.

B. Government survey data indicate the product is superior.

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

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

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

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.

According to ICH, which of the following components of study information is NOT required in a clinical study report?

A. Randomization scheme and codes

B. Protocol and protocol amendments

C. ListoflECsorlRBs

D. Detailed CVofall investigators