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NEW QUESTION 50
The intermediate manufacturing process was changed during development of a pharmaceutical. The change may impact the API specification. Which functional area is responsible for the final approval of the change?

• A. Production
• B. Analytical
• C. Regulatory
• D. Quality

Answer: D

NEW QUESTION 51
A company is considering the development of a medical device similar to those already available. Which of the following should be evaluated FIRST when developing a clinical evaluation document?

• A. Literature search
• B. Clinical investigations
• C. Adverse event reports
• D. Clinical experience

Answer: B

NEW QUESTION 52
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.

Answer: A

NEW QUESTION 53
After submission to the regulatory authority, a substantial error was found in the application. In order to resolve this issue, what should be done FIRST?

• A. Contact the legal department and ask them how to proceed.
• B. Inform upper management immediately.
• C. Resubmit the entire package.
• D. Verify the procedure in the regulation for the corrections.

Answer: D

NEW QUESTION 54
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 a minimum of 10 years after completion of the clinical study
• B. Until the product has been discontinued from marketing in all ICH regions
• C. Three years after the last clinical study site was supplied with investigational drugs
• D. For at least two years after the last approval of an application in an ICH region

Answer: D

NEW QUESTION 55
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