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NEW QUESTION 31
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 better brand-name drug in the same class.B. Develop a generic version of the drug.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: B

 

NEW QUESTION 32
In a distribution contract for high-risk medical devices, which of the following regulatory requirements is the MOST important for the distributor?

A. Service operation proceduresB. Written procedure for product traceabilityC. Training program for sales peopleD. Local reimbursement requirements

Answer: C

 

NEW QUESTION 33
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. Biological activity with species and/or tissue specificityB. Proposed dose and volume of administrationC. Proposed product route and frequency of administrationD. Immunochemical and functional tests

Answer: A

 

NEW QUESTION 34
During an audit of a contract manufacturing facility by a potential client, the auditor requested to be left alone in the records room. The records room contains information on all products produced by the contract manufacturer.
Which action is MOST appropriate for the regulatory affairs professional to take?

A. Allow the auditor access to the room and records due to the current audit.B. Deny the auditor access to the room and records due to confidentiality concerns.C. Allow the auditor accompanied access to the room to retrieve the records.D. Deny the auditor access to the room and retrieve only the requested records.

Answer: C

 

NEW QUESTION 35
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