Online Access Free RAC-US Practice Test

Company X is planning to acquire the rights for a product marketed by Company Y.
As part of due diligence, what is the MOST important information the Company X regulatory affairs professional should ask senior management to request from Company Y?

• A.Marketing materials
• B.Intellectual properly
• C.Safety issues
• D.Clinical trial data

Who has the PRIMARY responsibility for recall of products with quality defects?

• A.Regulatory authority
• B.Manufacturer
• C.Consumer
• D.Distributor

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

• A.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.
• B.The regulatory authority does not restrict physician prescribing for off-label indications or regulate the manufacturer's promotion for such use.
• C.The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby increasing access to much needed drugs and devices.
• D.Although the regulatory authority reviews and approves drugs for specific indications, the approval does not limit the use of those drugs in clinical practice.

Company X encounters challenges in the global life cycle management of its medical devices. Which of the following Is MOST appropriate for improving product life cycle management?

• A.Identify countries where special requirements exist during the product development phase.
• B.Utilize the STED template to complete global requirements.
• C.Plan regulatory approval update meetings with senior management and stakeholders.
• D.Initiate a global submission process after all submission data are finalized.

In order to develop a global drug product, what is the MOST important environmental characteristic to consider in the country of intended use?

• A.Product requirements
• B.Product formulation
• C.Product registration
• D.Product stability