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Question No 1: A physician reports to a manufacturer that a patient was hospitalized with acute sepsis after treatment with an approved device. This side effect is not listed in the package insert. This event must be reported by the manufacturer to FDA no later than: A. 5 calendar days. B. 15 calendar days C. 30 calendar days. D. The next quarterly or annual report. Answer: C https://best4exams.com/Exam/RAC-US


Question No 2: After completing the task assigned to you, what action you will do in JIRA on that task. A. Close B. Link C. Move D. Resolve Answer: D

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Question No 3: A company's supplier of the active drug substance for the company's OTC drug product informs the company that the supplier will be moving their production of the drug substance from the current plant to a new manufacturing plant in another state in 6 months. The supplier states that all manufacturing processes will remain the same and the specifications will not change. The company intends to qualify the change suitably. How should the company report the change to FDA? A. The change only needs to be reported in an annual report because the company will qualify the change and the supplier said the process and specifications won't change. B. The change should be reported in a pre-approval supplement (e.g., CBE, CBE-30 or full pre-approval supplement) because it is a change to the drug substance manufacturing location. C. The change does not have to be reported because it is an OTC drug. D. Not enough information. Answer: D https://best4exams.com/Exam/RAC-US


Question No 4: MDUFMA authorized 3rd party establishment inspections. All of the following are true about these inspections EXCEPT: A. You need to market at least one device in the United States. B. Participation is mandatory. C. In order to be eligible, an establishment's most recent inspection must be NAI or VAI. D. Establishments are not required to obtain clearance of a 3rd party in advance.

Answer: B https://best4exams.com/Exam/RAC-US


Question No 5: Which of the following federal laws includes information about ANDA submissions? A. Antibiotic Amendments of 1945 B. Durham-Humphrey Amendment of 1951 C. Drug Amendments of 1962 D. Drug Price Competition and Patent Term Restoration Act Answer: D

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RAC US Exam Dumps  

Now pass your RAC US exam on the first attempt by Best4Exams.com. They have best study material for the RAC US. Get your RAC US Dumps today...

RAC US Exam Dumps  

Now pass your RAC US exam on the first attempt by Best4Exams.com. They have best study material for the RAC US. Get your RAC US Dumps today...

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