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Free RAPS RAC-GS Exam Braindumps (page: 2)

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100 Questions & Answers
Page 2 of 26

A company's product was approved by a regulatory authority with the condition that further studies must be completed prior to full approval of the product.
To minimize product-associated risk to patients during the period of conditional approval, what is the LEAST effective way to achieve this goal?

  1. Label the product for use in appropriate populations.
  2. Educate patients and healthcare providers on how to use the product
  3. Delay product launch until required studies are completed.
  4. Promote off-label use to a carefully selected patient population.

Answer(s): D



A global company is developing a sophisticated implantable medical device that is coated with antibiotics and biologics to enhance its efficacy. The product is marketed in Country X. where it is regulated as a medical device. The same product, without theantibiotics and biologics, is marketed as a medical device in Country Y. The company is proposing to start marketing the coated device in Country Y. Which regulatory approach should the company propose?

  1. Submit the product for review as a pharmaceutical product in Country Y.
  2. Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.
  3. Apply for review of the additional part of the product as a pharmaceutical product in Country
  4. Examine decisions made about similar products in Country Y to propose the classification ofthe product.

Answer(s): C,D



Company X acquires Company Y. Both companies produce pharmaceuticals distributed globally. A regulatory authority requires that all labeling for Company Y's products be
converted to Company X within three months. The regulatory affairs professional at Company X concludes that it is not feasible to meet this request within the time frame.
Which is the FIRST step that the regulatory affairs professional at Company X should take to address the situation?

  1. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period from the regulatory authority.
  2. Request additional resources from senior management in order to complete the labeling conversion within the time frame given by the regulatory authority.
  3. Submit as many labelingconversion applications as possible within the time frame and request an extension for the remaining ones.
  4. Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority requirement and assign responsibilities.

Answer(s): A



A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for review and approval. The regulatory authority issues the company a written commitment that if the studies are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre- specified criteria, the company receives a letter from the regulatory authority stating that it no longer believes that the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?

  1. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the application.
  2. Consult with the legal department to discuss the best course of action.
  3. Review the regulatory guidelines to determine how to proceed.
  4. Request a meeting with the regulatory authority to discuss the application.

Answer(s): D






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