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NEW QUESTION 34
As a member of the product launch review committee, a regulatory affairs professional discovers a major issue with the labeling of a product prior to production. In addition to informing the committee, which is the BEST approach to address the issue?

  • A. Correct the label text.
  • B. Inform the regulatory authorities.
  • C. Delay the start of product production.
  • D. Abort the product launch.

Answer: B

 

NEW QUESTION 35
Which of the following claims would classify an apple as a drug?

  • A. "It will prevent colds."
  • B. "It will make you look younger."
  • C. "It will whiten teeth."
  • D. "It will satisfy hunger."

Answer: A

 

NEW QUESTION 36
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. 500 patients for three months
  • B. 3.000 total patient exposures
  • C. 100 patients for 12 months
  • D. 200 patients for nine months

Answer: C

 

NEW QUESTION 37
Which of the following statements regarding the off-label use of drugs is CORRECT?

  • A. Sponsors are allowed to distribute publications about unapproved uses of approved drugs and devices as long as the marketing application is under review by the regulatory authority.
  • B. The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby increasing access to much needed drugs and devices.
  • C. Although the regulatory authority reviews and approves drugs for specific indications, the approval does not limit the use of those drugs in clinical practice.
  • D. The regulatory authority does not restrict physician prescribing for off-label indications or regulate the manufacturer's promotion for such use.

Answer: C

 

NEW QUESTION 38
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