RAC-US Sample Practice Exam Questions 2025 Updated Verified
Exam Study Guide Free Practice Test LAST UPDATED RAC-US
To be eligible to take the RAC-US exam, candidates must have at least five years of professional experience in regulatory affairs, with at least two years of experience in the United States. Candidates must also have a bachelor's degree or higher in a relevant field, such as healthcare, science, or engineering. RAC-US exam is computer-based and consists of 120 multiple-choice questions, which must be completed within four hours. Candidates who pass the exam earn the RAC-US certification, which is valid for three years and can be renewed through continuing education and professional development.
NEW QUESTION # 31
Company X is planning to acquire the rights for a product marketed by Company Y.
As part of due diligence, what is the MOST important information the Company X regulatory affairs professional should ask senior management to request from Company Y?
- A. Clinical trial data
- B. Safety issues
- C. Intellectual properly
- D. Marketing materials
Answer: B
NEW QUESTION # 32
A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for review and approval. The regulatory authority issues the company a written commitment that if the studies are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre- specified criteria, the company receives a letter from the regulatory authority stating that it no longer believes that the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?
- A. Consult with the legal department to discuss the best course of action.
- B. Request a meeting with the regulatory authority to discuss the application.
- C. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the application.
- D. Review the regulatory guidelines to determine how to proceed.
Answer: B
NEW QUESTION # 33
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. Justification
- B. Property
- C. Formulation
- D. Specification
Answer: A
NEW QUESTION # 34
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. 100 patients for 12 months
- B. 3.000 total patient exposures
- C. 500 patients for three months
- D. 200 patients for nine months
Answer: A
NEW QUESTION # 35
According to ICH, how many stability time points are normally required to establish a two- year shelf life for a product?
- A. 0
- B. 1
- C. 2
- D. 3
Answer: A
NEW QUESTION # 36
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. Until the product has been discontinued from marketing in all ICH regions
- D. Three years after the last clinical study site was supplied with investigational drugs
Answer: A
NEW QUESTION # 37
At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?
- A. Regulatory agency
- B. Quality assurance
- C. Clinical affairs
- D. Quality improvement
Answer: B
NEW QUESTION # 38
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. Contact the regulatory authority to discuss its findings.
- C. Repeat the Hepatotoxicity tests and send the results to the regulatory authority.
- D. Wait for the regulatory authority's final publication on its findings.
Answer: B
NEW QUESTION # 39
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. Examine decisions made about similar products in Country Y to propose the classification of the product.
- C. Apply for review of the additional part of the product as a pharmaceutical product in Country
- D. Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.
Answer: C
NEW QUESTION # 40
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. "Has the product been approved for mor&4nan 10 years?"
- C. "Is the product an established gold standard?"
- D. "Is the product better than currently available alternatives?"
Answer: D
NEW QUESTION # 41
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. Quality
- B. Production
- C. Regulatory
- D. Analytical
Answer: A
NEW QUESTION # 42
According to WHO, what are the temperature and humidity conditions for a Zone IVb long- term stability study?
- A. 25: C and 60% RH
- B. 30c C and 65% RH
- C. 30: C and 75% RH
- D. 30 C and 35% RH
Answer: C
NEW QUESTION # 43
During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the medicinal products manufactured at the site is not GMP compliant. The product
Is distributed globally.
Which of the following is the most appropriate action to take FIRST?
- A. Send a "Dear Dr." letter to customers.
- B. Notify the global regulatory authorities.
- C. Withdraw the affected product from the markets.
- D. Assess the potential safety risk.
Answer: B
NEW QUESTION # 44
A company receives multiple complaints regarding the text included on a recently launched product's label. What action should the regulatory affairs professional take FIRST?
- A. Recommend an immediate product recall.
- B. Notify the regulatory authority.
- C. Compare the approved text with the product label
- D. Inform the production team.
Answer: C
NEW QUESTION # 45
Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?
- A. Introducing a new analytical method
- B. Strengthening a precaution to the product labeling
- C. Deleting an ingredient of the drug product
- D. Deleting a drug substance
Answer: B
NEW QUESTION # 46
Which of the following statements regarding export regulations for an approved product is CORRECT?
- A. The product must not be sold or offered for sale in domestic commerce.
- B. The product must not be labeled on the outside of the shipping package that it is intended for export.
- C. The product must not be in accord with the specifications of the foreign purchaser.
- D. The product must not be in conflict with the laws of the country to which it is intended for export.
Answer: D
NEW QUESTION # 47
Which of the following is the MOST desirable timing and approach for a regulatory affairs professional who wants to provide feedback on proposed new regulations?
- A. After the enactment of the regulation, through a product-specific meeting
- B. Before the enactment of the regulation, through the industry representative
- C. After the enactment of the regulation, through the industry representative
- D. Before the enactment of the regulation, through formal comments gathering process
Answer: D
NEW QUESTION # 48
The regulatory authority in Country X issued a request for a mandatory product recall in
Country X due to serious injuries to patients. This product also is distributed in Country Y.
What should the regulatory affairs professional of the product's manufacturer FIRST do in
Country Y?
- A. Review alt distribution records and complaints reported in Country Y.
- B. Prepare the legal team in Country Y for possible litigations.
- C. Draft a formal letter to customers in Country Y about this recall.
- D. Initiate a mandatory recall of the product in Country Y.
Answer: A
NEW QUESTION # 49
Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?
- A. Subject is hospitalized for the purpose of product administration.
- B. Subject's hospitalization is prolonged during the clinical trial.
- C. Subject's hospitalization is due to an unscheduled hip operation.
- D. Subject is hospitalized due to complications of the product administration.
Answer: A
NEW QUESTION # 50
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