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NEW QUESTION 29
What is the LAST stage in the development of a quality risk management process for a medical device?

A. Risk analysisB. Risk reductionC. Risk acceptanceD. Risk evaluation

Answer: C

 

NEW QUESTION 30
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 labelingB. Deleting an ingredient of the drug productC. Deleting a drug substanceD. Introducing a new analytical method

Answer: A

 

NEW QUESTION 31
Following the introduction of a new regulation, an evaluation of the company's products by the regulatory affairs professional indicates that 60 percent do not comply with the regulation.
What should the regulatory affairs professional do FIRST to meet the new requirement?

A. Contact the trade association for advice.B. Communicate with the relevant internal departments.C. Request a permanent waiver from the new regulation.D. Prepare documents for the files.

Answer: B

 

NEW QUESTION 32
Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?

A. Proposed product route and frequency of administrationB. Biological activity with species and/or tissue specificityC. Immunochemical and functional testsD. Proposed dose and volume of administration

Answer: B

 

NEW QUESTION 33
Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a reimbursement agency?

A. "Is the product better than currently available alternatives?"B. "Is the product profitable for the manufacturer?"C. "Has the product been approved for mor&4nan 10 years?"D. "Is the product an established gold standard?"

Answer: A

 

NEW QUESTION 34
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