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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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