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NEW QUESTION 33
In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?

A. Compatibility and safetyB. Volume and materialC. Efficacy and materialD. Safety and efficacy

Answer: A

 

NEW QUESTION 34
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 an established gold standard?"C. "Has the product been approved for mor&4nan 10 years?"D. "Is the product profitable for the manufacturer?"

Answer: A

 

NEW QUESTION 35
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?

A. Site licenseB. Product licenseC. Import licenseD. Export license

Answer: A

 

NEW QUESTION 36
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. Communicate with the relevant internal departments.B. Contact the trade association for advice.C. Prepare documents for the files.D. Request a permanent waiver from the new regulation.

Answer: A

 

NEW QUESTION 37
A superiority advertising claim for a product versus its competitor's product can only be made under which of the following circumstances?

A. In vitro studies show the product to be superior.B. Government survey data indicate the product is superior.C. Results of a three-year, post-market patient survey indicate the product is superior.D. Results of adequate, well-controlled comparative clinical trial show the product is superior.

Answer: D

 

NEW QUESTION 38
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