RAC-US Dumps PDF - 100% Success with these Questions | Dumps4download

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2. Question: 1 A superiority advertising claim for a product versus its competitor's product can only be made under which of the following circumstances? A. In vitro studies show the product to be superior. B. Government survey data indicate the product is superior. C. Results of a three-year, post-market patient survey indicate the product is superior. D. Results of adequate, well-controlled comparative clinical trial show the product is superior. Answer: D Question: 2 A regulatory affairs professional is asked to review and update regulatory affairs SOPs. Which aspect of the SOP Is MOST important to consider? A. Expiration date B. Relevance to regulations C. Revision history D. Scope and level of detail Answer: B Question: 3 Which term does NOT describe the same concept as the others? A. Biosimilars B. Follow-on protein products C. Monoclonal antibody D. Subsequent entry biologics Answer: C Question: 4 A company is developing a new product for the global market. A new international guideline will recommend relevant studies in the pediatric population, and the guideline will be effective before the approval of the company's new product. Visit us athttps://www.examsboost.com/test/rac-us/

3. What is the BEST advice the regulatory affairs professional can provide to minimize the impact of this guideline on the successful registration of the new product? A. The company should consult with relevant regulatory authorities to determine the potential impact on the current registration plan. B. The new guideline has no impact on the current registration plan, but the company must be prepared to defend its decision. C. The new guideline has no impact on the current registration plan since all relevant registration studies are almost completed. D. The company should initiate the required pediatric studies immediately to avoid costly delays to the current registration plan. Answer: A Question: 5 SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following? A. Inadequate training B. Late and/or incorrect deliverables C. Causes of non-conformities D. Adverse environmental impacts Answer: C Question: 6 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? A. Label the product for use in appropriate populations. B. Educate patients and healthcare providers on how to use the product C. Delay product launch until required studies are completed. D. Promote off-label use to a carefully selected patient population. Answer: D Visit us athttps://www.examsboost.com/test/rac-us/

4. Question: 7 During the review of a design dossier, the reviewer asks why the company has only carried out a top- down risk approach. The reviewer is referring to which of the following? A. ISO 14971 risk analysis B. Failure mode and effect analysis C. Fault tree analysis D. Hazard and operability study Answer: A Question: 8 A company is considering the development of a medical device similar to those already available. Which of the following should be evaluated FIRST when developing a clinical evaluation document? A. Adverse event reports B. Clinical experience C. Clinical investigations D. Literature search Answer: C Question: 9 A clinical study of a drug is completed to support a marketing approval application. According to ICH, how long should a sponsor retain the clinical study essential documents? A. For at least two years after the last approval of an application in an ICH region B. For a minimum of 10 years after completion of the clinical study C. Three years after the last clinical study site was supplied with investigational drugs D. Until the product has been discontinued from marketing in all ICH regions Answer: A Visit us athttps://www.examsboost.com/test/rac-us/

5. Question: 10 The regulatory authority contacts the regulatory affairs professional regarding a complaint about a drug produced by the company. A consumer reported to the regulatory authority that the tablets have a slightly different color and break easily. Which of the following actions should the regulatory affairs professional take? A. Ask that the regulatory authority provide the batch number printed on the packaging of the affected product. B. Ask that the regulatory authority provide the actual product subject to the complaint. C. Respond to the regulatory authority that the product subject to the complaint is most likely a counterfeit product. D. Respond to the regulatory authority that the company will provide copies of the relevant QC records for batch release. Answer: A Visit us athttps://www.examsboost.com/test/rac-us/

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