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NEW QUESTION 25
During routine surveillance, a regulatory authority sent a company the following communication: "Hepatotoxicity and suicidal behavior were identified as potential safety issues for the company's product. The regulatory authority is evaluating these issues to determine the need for any regulatory action." Which action would be the most appropriate
FIRST step for the company to take?
- A. Contact the regulatory authority to argue that its conclusions are wrong.
- B. Repeat the Hepatotoxicity tests and send the results to the regulatory authority.
- C. Wait for the regulatory authority's final publication on its findings.
- D. Contact the regulatory authority to discuss its findings.
Answer: D
NEW QUESTION 26
A request was received from a regulatory authority asking the company to conduct product testing in compliance with a newly issued regulation.
What should be done. What action should the company take FIRST?
- A. Initiate testing immediately to ensure compliance.
- B. Contact the regulatory authority that issued this request and discuss the requirement.
- C. Send a letter back to the regulatory authority indicating why the regulation does not apply to the product.
- D. Consult with colleagues about the request.
Answer: B
NEW QUESTION 27
Which of the following situations does NOT require rapid communication to regulatory authorities?
- A. A lack of efficacy with a medicinal product used in treating a life-threatening disease
- B. A major safety finding from a newly completed animal carcinogenicity study
- C. A statistically significant increase in the number of deaths in an animal dose finding study
- D. A clinically important increase in the rate of occurrence of an "expected." but serious
ADR
Answer: D
NEW QUESTION 28
In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?
- A. Compatibility and safety
- B. Volume and material
- C. Efficacy and material
- D. Safety and efficacy
Answer: A
NEW QUESTION 29
Which of the following BEST describes the content of the "Physical, Chemical, and
Pharmaceutical Properties and Formulation" section of an IB?
- A. A description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product
- B. A brief summary of relevant physical, chemical, and pharmaceutical properties:
instructions for storage and handling of the dosage form: and a description of the formulation - C. A review of available data to support the determination of the chemical structure and physical attributes of the drug substance plus batch analysis and stability data for the finished formulation
- D. A detailed summary of the physical and chemical properties of the drug product with a signed expert statement addressing the suitability and stability of the formulation for its intended use
Answer: B
NEW QUESTION 30
In order to develop a global drug product, what is the MOST important environmental characteristic to consider in the country of intended use?
- A. Product requirements
- B. Product registration
- C. Product stability
- D. Product formulation
Answer: C
NEW QUESTION 31
Which of the following double-blind clinical trial designs would be MOST appropriate for a
Phase III study with a new product intended to treat an acute life-threatening disease with less than optimal available therapy?
- A. Active-controlled
- B. Cross-over
- C. Placebo-controlled
- D. Dose-ranging
Answer: B
NEW QUESTION 32
The safety database for an anti-hypertensive drug consists of the following:
* 461 patients exposed for three months
* 343 patients exposed for six months
* 112 patients exposed for nine months
* 74 patients exposed for 12 months
Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?
- A. 3.000 total patient exposures
- B. 100 patients for 12 months
- C. 500 patients for three months
- D. 200 patients for nine months
Answer: B
NEW QUESTION 33
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?
- A. Train all new employees on regulatory compliance processes and assign a mentor to them.
- B. Document any failure to follow regulatory compliance processes in employee performance reviews.
- C. Develop documented procedures for regulatory compliance processes and train personnel.
- D. Train employees on all regulatory compliance processes using state-of-the-art systems.
Answer: C
NEW QUESTION 34
Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?
- A. Subject's hospitalization is due to an unscheduled hip operation.
- B. Subject is hospitalized due to complications of the product administration.
- C. Subject's hospitalization is prolonged during the clinical trial.
- D. Subject is hospitalized for the purpose of product administration.
Answer: D
NEW QUESTION 35
Which of the following claims would classify an apple as a drug?
- A. "It will prevent colds."
- B. "It will satisfy hunger."
- C. "It will whiten teeth."
- D. "It will make you look younger."
Answer: A
NEW QUESTION 36
At a recent scientific meeting, Company Y had two booths:
* At one booth, Company Y provided brochures on a completed Phase II study.
* In an adjacent booth, Company Y's sales professionals were promoting one of Company
Y's marketed products.
A regulatory affairs-professional at Company X sends a letter to a counterpart at Company
Y requesting that Company Y stop this practice in the future and demanding a formal response to the letter. How should the regulatory affairs professional at Company Y BEST respond?
- A. Inform Company X that it has no right to send such a letter and do nothing further.
- B. Acknowledge receipt of the letter in a written response but do nothing further.
- C. Inform the local regulatory authority of the letter and discuss how to respond.
- D. Inform the legal department of the letter and discuss how to respond.
Answer: D
NEW QUESTION 37
As a member of the product launch review committee, a regulatory affairs professional discovers a major issue with the labeling of a product prior to production. In addition to informing the committee, which is the BEST approach to address the issue?
- A. Correct the label text.
- B. Inform the regulatory authorities.
- C. Abort the product launch.
- D. Delay the start of product production.
Answer: B
NEW QUESTION 38
Which of the following is the PRIMARY purpose of an audit report?
- A. To carry out a complete review of product applications
- B. To document compliance history
- C. To define how to prepare new product submissions
- D. To train sales representatives
Answer: B
NEW QUESTION 39
According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?
- A. Class D
- B. Class A
- C. Class B
- D. Class C
Answer: D
NEW QUESTION 40
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RAC-US exam questions from ActualTestsQuiz dumps: https://www.actualtestsquiz.com/RAC-US-test-torrent.html (100 Q&As)
Free 2021 RAC Regulatory Affairs Certification RAC-US dumps are available on Google Drive shared by ActualTestsQuiz: https://drive.google.com/open?id=1Xd5Gc4wPHRQ0lSdrK_eynKfbQFxBPW2-
