New BraindumpsVCE RAC-US Exam Questions| Real RAC-US Dumps Updated on Oct 18, 2022
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NEW QUESTION 25
A company is developing a new medical device.
During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?
- A. Concept development and validation
- B. Concept development and early technical design
- C. Product release and validation
- D. Early technical design and product release
Answer: B
NEW QUESTION 26
A global company has obtained a patent in a specific country for a newly marketed product.
What would be the BEST advice In order to protect the patent in other countries?
- A. File design patents in target countries.
- B. Use the community patent system.
- C. Use the Madrid system.
- D. File patents of interest in target countries.
Answer: D
NEW QUESTION 27
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 the antibiotics 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?
- A. Submit the product for review as a pharmaceutical product in Country Y.
- B. Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.
- C. Apply for review of the additional part of the product as a pharmaceutical product in Country
- D. Examine decisions made about similar products in Country Y to propose the classification of the product.
Answer: C
NEW QUESTION 28
According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?
- A. Malfunction occurring before the end of service life of the medical device
- B. Malfunction protection operated correctly
- C. Deficiency of a device found by the user prior to patient use
- D. Adverse event caused by patient conditions
Answer: D
NEW QUESTION 29
According to ICH, which of the following components of study information is NOT required in a clinical study report?
- A. Randomization scheme and codes
- B. List of lECs or lRBs
- C. Protocol and protocol amendments
- D. Detailed CV of all investigators
Answer: D
NEW QUESTION 30
In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?
- A. Compatibility and safety
- B. Efficacy and material
- C. Safety and efficacy
- D. Volume and material
Answer: A
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. Dose-ranging
- B. Cross-over
- C. Active-controlled
- D. Placebo-controlled
Answer: B
NEW QUESTION 32
During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic.
What should be done in response to identifying the impurity?
- A. Perform both identification and non-clinical qualification studies concurrently.
- B. Perform either an identification study or a non-clinical qualification study.
- C. Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.
- D. Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.
Answer: D
NEW QUESTION 33
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 B
- C. Class C
- D. Class A
Answer: C
NEW QUESTION 34
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?
- A. Site license
- B. Import license
- C. Export license
- D. Product license
Answer: A
NEW QUESTION 35
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
- A. Phase I and II clinical trials
- B. Phase I clinical trials
- C. Phase III clinical trials
- D. Pre-clinical studies
Answer: C
NEW QUESTION 36
Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?
- A. Strengthening a precaution to the product labeling
- B. Deleting an ingredient of the drug product
- C. Deleting a drug substance
- D. Introducing a new analytical method
Answer: A
NEW QUESTION 37
A drug product presents degradation during the manufacturing process. In addition to the amount, what information should be provided FIRST in order to use API overage?
- A. Formulation
- B. Specification
- C. Justification
- D. Property
Answer: C
NEW QUESTION 38
Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a reimbursement agency?
- A. "Is the product profitable for the manufacturer?"
- B. "Is the product better than currently available alternatives?"
- C. "Is the product an established gold standard?"
- D. "Has the product been approved for mor&4nan 10 years?"
Answer: B
NEW QUESTION 39
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. 500 patients for three months
- B. 3.000 total patient exposures
- C. 200 patients for nine months
- D. 100 patients for 12 months
Answer: D
NEW QUESTION 40
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 for the purpose of product administration.
- C. Subject's hospitalization is prolonged during the clinical trial.
- D. Subject is hospitalized due to complications of the product administration.
Answer: B
NEW QUESTION 41
Which of the following claims would classify an apple as a drug?
- A. "It will whiten teeth."
- B. "It will make you look younger."
- C. "It will satisfy hunger."
- D. "It will prevent colds."
Answer: D
NEW QUESTION 42
A company is currently marketing an implantable orthopedic medical device. The R&D department is planning to change the material used for the implant. The R&D department states that the change does not impact the safety and effectiveness of the product.
What action should the regulatory affairs professional take FIRST?
- A. No action is needed in this situation.
- B. Write a memo to file since the change does not impact product safety and effectiveness.
- C. Review the content of change and supporting data for the equivalency with the current material.
- D. Prepare regulatory submissions that detail the medical device's change in materials.
Answer: C
NEW QUESTION 43
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. Educate patients and healthcare providers on how to use the product
- B. Promote off-label use to a carefully selected patient population.
- C. Delay product launch until required studies are completed.
- D. Label the product for use in appropriate populations.
Answer: B
NEW QUESTION 44
The intermediate manufacturing process was changed during development of a pharmaceutical. The change may impact the API specification. Which functional area is responsible for the final approval of the change?
- A. Regulatory
- B. Quality
- C. Production
- D. Analytical
Answer: B
NEW QUESTION 45
An inspection of a manufacturing site determines that a number of manufacturing changes have been implemented without obtaining the necessary regulatory clearance. Which of the following actions should the regulatory affairs professional complete FIRST?
- A. Assess the impact of the changes.
- B. Review the stability data for the changes.
- C. Establish validation procedures.
- D. Stop product manufacturing.
Answer: D
NEW QUESTION 46
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. Repeat the Hepatotoxicity tests and send the results to the regulatory authority.
- B. Contact the regulatory authority to argue that its conclusions are wrong.
- C. Contact the regulatory authority to discuss its findings.
- D. Wait for the regulatory authority's final publication on its findings.
Answer: C
NEW QUESTION 47
According to the ICH guideline on GMP for API, to which of the following is the MOST stringent requirement applied?
- A. Physical processing and packaging
- B. Isolation and purification
- C. Introduction of the API starting material
- D. Production of Intermediate(s)
Answer: A
NEW QUESTION 48
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
NEW QUESTION 49
A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?
- A. Individual plasma donation
- B. Plasma fractionation
- C. Plasma pooling
- D. Product distribution
Answer: D
NEW QUESTION 50
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