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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.
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."
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
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.
NEW QUESTION 38