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NEW QUESTION 24
Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a reimbursement agency?

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

Answer: C

 

NEW QUESTION 25
Company X is planning to acquire the rights for a product marketed by Company Y.
As part of due diligence, what is the MOST important information the Company X regulatory affairs professional should ask senior management to request from Company Y?

A. Intellectual properlyB. Safety issuesC. Marketing materialsD. Clinical trial data

Answer: B

 

NEW QUESTION 26
What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?

A. Quality and effectivenessB. Safety and failure riskC. Safety and effectivenessD. Quality and failure risk

Answer: C

 

NEW QUESTION 27
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