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.

Which term does NOT describe the same concept as the others?

A. Biosimilars

B. Follow-on protein products

C. Monoclonal antibody

D. Subsequent entry biologics

Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication?

A. "Product X is a guaranteed cure for arthritis."

B. "Product X is effective for the treatment of arthritis."

C. "Product X is safe for arthritis and without side effects."

D. "Product X is effective in all patients with arthritis."

Which of the following BEST describes the process of post-marketing surveillance for healthcare products?

A. Systematic procedure to review published scientific journals

B. Systematic procedure to review experiences with the products in use

C. Vigilance procedure to ensure the full traceability of the products

D. Vigilance procedure to notify the regulatory authorities about serious incidents

At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?

A. Quality improvement

B. Quality assurance

C. Clinical affairs

D. Regulatory agency

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?

A. Before the enactment of the regulation, through the industry representative

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

C. After the enactment of the regulation, through the industry representative

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

Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?

A. Subject is hospitalized due to complications of the product administration.

B. Subject is hospitalized for the purpose of product administration.

C. Subject's hospitalization is due to an unscheduled hip operation.

D. Subject's hospitalization is prolonged during the clinical trial.

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.

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.

Which of the following BEST describes the content of the "Physical, Chemical, and Pharmaceutical Properties and Formulation" section of an IB?

A. A review of available data to support the determination of the chemical structure and physical attributes of the drug substance plus batch analysis and stability data for the finished formulation

B. A detailed summary of the physical and chemical properties of the drug product with a signed expert statement addressing the suitability and stability of the formulation for its intended use

C. A description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product

D. A brief summary of relevant physical, chemical, and pharmaceutical properties: instructions for storage and handling of the dosage form: and a description of the formulation