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NEW QUESTION 40
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. "Has the product been approved for mor&4nan 10 years?"
- C. "Is the product better than currently available alternatives?"
- D. "Is the product an established gold standard?"
Answer: C
NEW QUESTION 41
The safety database for an anti-hypertensive drug consists of the following:
* 461 patients exposed for three months
* 343 patients exposed for six months
* 112 patients exposed for nine months
* 74 patients exposed for 12 months
Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?
- A. 3.000 total patient exposures
- B. 100 patients for 12 months
- C. 500 patients for three months
- D. 200 patients for nine months
Answer: B
NEW QUESTION 42
The regulatory authority contacts the regulatory affairs professional regarding a complaint about a drug produced by the company. A consumer reported to the regulatory authority that the tablets have a slightly different color and break easily.
Which of the following actions should the regulatory affairs professional take?
- A. Respond to the regulatory authority that the company will provide copies of the relevant
QC records for batch release. - B. Respond to the regulatory authority that the product subject to the complaint is most likely a counterfeit product.
- C. Ask that the regulatory authority provide the batch number printed on the packaging of the affected product.
- D. Ask that the regulatory authority provide the actual product subject to the complaint.
Answer: C
NEW QUESTION 43
A company is developing a line of products for which no ISO standard of performance is available. As a result, the company wishes to propose developing such a standard. Whom should the company contact in order to start the development of the new standard?
- A. The ISO Secretariat
- B. The ISO technical committee in charge of the area
- C. The ISO national member body
- D. The country's regulatory authority
Answer: C
NEW QUESTION 44
The requirements for document control are located in which of the following documents?
- A. WHO guidelines
- B. IEC 60601
- C. ISO 13485
- D. ICH guidelines
Answer: C
NEW QUESTION 45
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