RAC-US RELIABLE GUIDE FILES & VALID RAC-US CRAM MATERIALS

RAC-US Reliable Guide Files & Valid RAC-US Cram Materials

RAC-US Reliable Guide Files & Valid RAC-US Cram Materials

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Tags: RAC-US Reliable Guide Files, Valid RAC-US Cram Materials, RAC-US Exam Prep, New RAC-US Dumps Ppt, Reliable RAC-US Dumps Book

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RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q66-Q71):

NEW QUESTION # 66
Which of the following statements regarding export regulations for an approved product is CORRECT?

  • A. The product must not be sold or offered for sale in domestic commerce.
  • B. The product must not be in accord with the specifications of the foreign purchaser.
  • C. The product must not be in conflict with the laws of the country to which it is intended for export.
  • D. The product must not be labeled on the outside of the shipping package that it is intended for export.

Answer: C


NEW QUESTION # 67
According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?

  • A. Class C
  • B. Class A
  • C. Class B
  • D. Class D

Answer: A


NEW QUESTION # 68
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. "Is the product better than currently available alternatives?"
  • C. "Is the product an established gold standard?"
  • D. "Has the product been approved for mor&4nan 10 years?"

Answer: B


NEW QUESTION # 69
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. 200 patients for nine months
  • C. 100 patients for 12 months
  • D. 3.000 total patient exposures

Answer: C


NEW QUESTION # 70
During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic.
What should be done in response to identifying the impurity?

  • A. Perform either an identification study or a non-clinical qualification study.
  • B. Perform both identification and non-clinical qualification studies concurrently.
  • C. Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.
  • D. Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.

Answer: D


NEW QUESTION # 71
......

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