A company is developing a new medical device using innovative technology. Which of the following is
MOST critical in working with regulatory authorities?

• A.Early collaboration
• B.Follow-up meeting after submission
• C.Documented agreement
• D.Frequent communication

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

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Company X has a patent for an anti-inflammatory drug that will expire in one year. In order to minimize the
effect of the patent expiration, which is the BEST action for the company to take?

• A.Develop a generic version of the drug.
• B.Explore litigation strategy for patent infringements on the drug.
• C.Conduct a Phase III study for a new unrelated indication of the drug.
• D.Develop a better brand-name drug in the same class.

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According to the ICH guideline on GMP for API, to which of the following is the MOST stringent
requirement applied?

• A.Introduction of the API starting material
• B.Physical processing and packaging
• C.Isolation and purification
• D.Production of Intermediate(s)

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

• A.Vigilance procedure to ensure the full traceability of the products
• B.Vigilance procedure to notify the regulatory authorities about serious incidents
• C.Systematic procedure to review published scientific journals
• D.Systematic procedure to review experiences with the products in use

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