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Free RAC-GS Exam Braindumps

During a routine review of promotional materials for a product, a regulatory affairs professional discovers an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory affairs professional to take?

  1. Allow doctors to use the product for the off-label indication.
  2. Communicate with the sales department to stop using the promotional materials.
  3. Contact the marketing department to recall the product.
  4. Request that doctors stop using the product for the off-label indication.

Answer(s): B



The intermediate manufacturing process was changed during development of a pharmaceutical. The change may impact the API specification. Which functional area is responsible for the final approval of the change?

  1. Production
  2. Analytical
  3. Quality
  4. Regulatory

Answer(s): C,D



Following the introduction of a new regulation, an evaluation of the company's products by the regulatory affairs professional indicates that 60 percent do not comply with the regulation.
What should the regulatory affairs professional do FIRST to meet the new requirement?

  1. Contact the trade association for advice.
  2. Communicate with the relevant internal departments.
  3. Prepare documents for the files.
  4. Request a permanent waiver from the new regulation.

Answer(s): B



Which of the following is MOST appropriate for the purpose of lot release of biologics?

  1. Inventory control
  2. Safety assurance
  3. Efficacy confirmation
  4. Quality verification

Answer(s): D






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Raymond commented on May 02, 2022
Best way to cheat your exam. hahaha... all questions are in this dexam dump.
UNITED STATES
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