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NEW QUESTION 52
A global company is developing a sophisticated implantable medical device that is coated with antibiotics and biologics to enhance its efficacy.
The product is marketed in Country X.
where it is regulated as a medical device.
The same product, without the antibiotics and biologics, is marketed as a medical device in Country Y.
The company is proposing to start marketing the coated device in Country Y.
Which regulatory approach should the company propose?

  • A. Examine decisions made about similar products in Country Y to propose the classification of the product.
  • B. Apply for review of the additional part of the product as a pharmaceutical product in Country
  • C. Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.
  • D. Submit the product for review as a pharmaceutical product in Country Y.

Answer: B

 

NEW QUESTION 53
A regulation change is imminent and may require further non-clinical testing on a product currently in Phase III clinical trials. What is the most appropriate action to take FIRST?

  • A. Consult with the company's legal department regarding options.
  • B. Inform the company's senior management and arrange an emergency meeting
  • C. Obtain a copy of the proposed regulation and analyze the impact.
  • D. Arrange for additional testing of the product at the testing facility.

Answer: C

 

NEW QUESTION 54
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. 200 patients for nine months
  • D. 500 patients for three months

Answer: B

 

NEW QUESTION 55
During several monitoring visits, a clinical trial monitor identifies serious and repeated noncompliance on the part of the PI. What action should the sponsor take?

  • A. Send a letter of complaint to the Ethics Committee that approved the site.
  • B. Increase the frequency of monitoring visits.
  • C. Terminate the PI and inform the regulatory authorities.
  • D. Inform the institution that granted a medical license to the Pi.

Answer: C

 

NEW QUESTION 56
Which of the following BEST describes the purpose of the ICH?

  • A. To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions
  • B. To provide scientific evaluation of applications for international marketing authorization for safe, effective, and high-quality medicines for the ICH regions
  • C. To lobby for improved industry standards for the development of new safe, effective, and high-quality medicines for the ICH regions
  • D. To protect and promote public health through the evaluation and supervision of safe, effective, and high-quality medicines for the ICH regions

Answer: A

 

NEW QUESTION 57
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