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RAC US Exam Questions

Are you looking for RAPS Certification RAC US Exam Dumps? You are at the right place. We provide you real exam questions along with 100% passing assurance and money back guarantee. RAC US Exam Questions compiled by the professional experts. Visit us today and get free RAC US Braindumps PDF file free. Feel free to ask anything about the RAPS RAC US Exam.<br>https://www.exactcert.com/RAC-US-exam-questions.html<br>

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RAC US Exam Questions

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  1. Learn Why RAPS RAC US Dumps is important for your RAC US Exam Preparation?

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  8. QuestionNo 1: The Food and Drug Administration Modernization Act (FDAMA) established two types of formal early collaboration meetings. Which of the following is one of those meetings? A. PDP meeting B. Agreement Meeting C. Pre-IDE meeting D. Type A meeting Answer: B https://www.exactcert.com/RAC-US-exam-questions.html

  9. QuestionNo 2: A sponsor intends to submit a Special Protocol Assessment (SPA) request for a clinical trial that will form the primary basis of an efficacy claim in an NDA. Which of the following is TRUE? A. The sponsor should submit the SPA request within 30 days following the start of the trial to expedite FDA feedback B. An SPA provides an opportunity to focus on general drug development issues C. The SPA request will be handled as a request for a Type B meeting D. A sponsor can submit a revised protocol while the agency is reviewing an earlier version of the same protocol Answer: D https://www.exactcert.com/RAC-US-exam-questions.html

  10. QuestionNo 3: Devices that are exempt from premarket notification are: A. All Class I devices B. Some Class I devices C. Most Class I devices and some Class II devices D. All Class I devices and some Class II devices Answer: C https://www.exactcert.com/RAC-US-exam-questions.html

  11. QuestionNo 4: Your company wishes to seek approval of a combination of individually approved anti-hypertensive and anti-diabetic drugs. However, there is no Reference Listed Drug (RLD) for the proposed combination. Which of the following regulatory pathways is most applicable? A. 505(b)(2) B. 510(k) C. 505(b)(1) D. 505(j) Answer: A https://www.exactcert.com/RAC-US-exam-questions.html

  12. QuestionNo 5: The following applies to autologous chondrocytes expanded in vitro for the repair of cartilage defects: A. Regulated under Section 351 of the Public Health Service Act and no premarket approval required B. Regulated under Section 351 of the Public Health Service Act and premarket approval required C. Regulated under Section 361 of the Public Health Service Act and no premarket approval required D. Regulated under Section 361 of the Public Health Service Act and premarket approval required Answer: B https://www.exactcert.com/RAC-US-exam-questions.html

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