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Free RAC-GS Exam Braindumps (page: 4)

Page 3 of 26
PDF with 100 Questions

Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication?

  1. "Product X is a guaranteed cure for arthritis."
  2. "Product X is effective for the treatment of arthritis."
  3. "Product X is safe for arthritis and without side effects."
  4. "Product X is effective in all patients with arthritis."

Answer(s): B



After numerous failed attempts to decrease an identified risk in a medical device to an acceptable level, the medical device continues to have unacceptable risks. However, the development team wants to continue development. Which is the BEST recommendation to make in this situation?

  1. Add a warning in the IFU.
  2. Discontinue the project.
  3. Perform another risk-benefit analysis.
  4. Redesign the device.

Answer(s): D



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?

  1. 100 patients for 12 months
  2. 200 patients for nine months
  3. 500 patients for three months
  4. 3.000 total patient exposures

Answer(s): A



A company receives multiple complaints regarding the text included on a recently launched product's label. What action should the regulatory affairs professional take FIRST?

  1. Recommend an immediate product recall.
  2. Compare the approved text with the product label
  3. Notify the regulatory authority.
  4. Inform the production team.

Answer(s): B






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