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

Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?

• A. Strengthening a precaution to the product labeling
• B. Introducing a new analytical method
• C. Deleting a drug substance
• D. Deleting an ingredient of the drug product

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

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

According to ICH, what is the MAXIMUM amount of time in calendar days that an organization has from the initial receipt of information to report serious and unexpected ADR of a marketed product to regulatory authorities?

• A. 3
• B. 10
• C. 5
• D. 15

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?

• A. Deny the auditor access to the room and retrieve only the requested records.
• B. Allow the auditor access to the room and records due to the current audit.
• C. Deny the auditor access to the room and records due to confidentiality concerns.
• D. Allow the auditor accompanied access to the room to retrieve the records.