Prepare RAC-US Exam Questions [2026] Recently Updated Questions [Q23-Q43]

May 10, 2026 RAC-US, RAPS 0 Comments

Prepare RAC-US Exam Questions [2026] Recently Updated Questions [Q23-Q43]

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Prepare RAC-US Exam Questions [2026] Recently Updated Questions

Give push to your success with RAC-US exam questions

RAPS RAC-US certification is highly respected in the healthcare industry and is recognized by employers around the world. Regulatory Affairs Certification (RAC) US certification demonstrates a regulatory professional’s commitment to their profession and their expertise in regulatory affairs. It also provides a competitive advantage in the job market and can lead to career advancement opportunities.

NEW QUESTION 23
Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?

Deleting an ingredient of the drug product

Deleting a drug substance

Introducing a new analytical method

Strengthening a precaution to the product labeling

NEW QUESTION 24
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?

Production

Analytical

Quality

Regulatory

NEW QUESTION 25
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?

Active-controlled

Cross-over

Dose-ranging

Placebo-controlled

NEW QUESTION 26
Which of the following statements regarding the off-label use of drugs is CORRECT?

Although the regulatory authority reviews and approves drugs for specific indications, the approval does not limit the use of those drugs in clinical practice.

The regulatory authority does not restrict physician prescribing for off-label indications or regulate the manufacturer’s promotion for such use.

Sponsors are allowed to distribute publications about unapproved uses of approved drugs and devices as long as the marketing application is under review by the regulatory authority.

The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby increasing access to much needed drugs and devices.

NEW QUESTION 27
A company is developing a new line of products in an area that is new to the company.
What is the BEST approach?

Ask the trade association representative to provide an overview of the new product area to the marketing team.

Obtain competitor research and provide the information to the management team.

Obtain regulatory documents and history and provide the information to R&D.

Summarize regulatory documents and history and provide the information to the management team.

NEW QUESTION 28
In order to develop a global drug product, what is the MOST important environmental characteristic to consider in the country of intended use?

Product stability

Product registration

Product formulation

Product requirements

NEW QUESTION 29
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?

Acknowledge receipt of the letter in a written response but do nothing further.

Inform the legal department of the letter and discuss how to respond.

Inform Company X that it has no right to send such a letter and do nothing further.

Inform the local regulatory authority of the letter and discuss how to respond.

NEW QUESTION 30
A regulatory authority announces an inspection of a regulatory affairs professional’s facility during a holiday season when most of the staff Is not available. What is the MOST practical approach to this dilemma?

Negotiate with colleagues and the authority to find a better time.

Insist that key personnel be available for the inspection.

Inform the authority that the time is not suitable and request a new time

Arrange for an inspection without all intended personnel.

NEW QUESTION 31
A regulatory affairs professional has submitted a package for regulatory review.
According to the regulation, the regulatory authority will need to respond within 90 days of submission.
If there is no response after the deadline, what is the BEST approach?

Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.

Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission.

Contact the local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.

Contact the company legal representative in order to begin legal proceedings to enforce the regulatory authority’s response time.

NEW QUESTION 32
A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?

Expiration date

Relevance to regulations

Revision history

Scope and level of detail

NEW QUESTION 33
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?

Before the enactment of the regulation, through the industry representative

Before the enactment of the regulation, through formal comments gathering process

After the enactment of the regulation, through the industry representative

After the enactment of the regulation, through a product-specific meeting

NEW QUESTION 34
Company X acquires Company Y.
Both companies produce pharmaceuticals distributed globally. A regulatory authority requires that all labeling for Company Y’s products be converted to Company X within three months. The regulatory affairs professional at
Company X concludes that it is not feasible to meet this request within the time frame.
Which is the FIRST step that the regulatory affairs professional at Company X should take to address the situation?

Develop a plan of action with tasks, timelines, and responsibilities and request an extension period from the regulatory authority.

Request additional resources from senior management in order to complete the labeling conversion within the time frame given by the regulatory authority.

Submit as many labeling conversion applications as possible within the time frame and request an extension for the remaining ones.

Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority requirement and assign responsibilities.

NEW QUESTION 35
According to ISO 14971, what is the FIRST step when developing a risk management plan for a medical device?

Risk estimation

Risk analysis

Risk control

Risk management

NEW QUESTION 36
What is the LAST stage in the development of a quality risk management process for a medical device?

Risk analysis

Risk reduction

Risk acceptance

Risk evaluation

NEW QUESTION 37
Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication?

“Product X is a guaranteed cure for arthritis.”

“Product X is effective for the treatment of arthritis.”

“Product X is safe for arthritis and without side effects.”

“Product X is effective in all patients with arthritis.”

NEW QUESTION 38
In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?

Volume and material

Compatibility and safety

Safety and efficacy

Efficacy and material

NEW QUESTION 39
In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation.
However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?

Discuss with the regulatory apriority and attempt to reach an acceptable solution.

Inform the internal departments to redesign the product to comply with this requirement.

Inform the regulatory authority that such a requirement is not applicable to the product.

Notify senior management that the product cannot be registered.

NEW QUESTION 40
During an audit of a contract manufacturing facility by a potential client, the auditor requested to be left alone in the records room. The records room contains information on all products produced by the contract manufacturer.
Which action is MOST appropriate for the regulatory affairs professional to take?

Allow the auditor access to the room and records due to the current audit.

Allow the auditor accompanied access to the room to retrieve the records.

Deny the auditor access to the room and retrieve only the requested records.

Deny the auditor access to the room and records due to confidentiality concerns.

NEW QUESTION 41
GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation based on which of the following?

Instructions for use

Risk analysis

Product literature

Essential principles

NEW QUESTION 42
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?

Draft a formal letter to customers in Country Y about this recall.

Initiate a mandatory recall of the product in Country Y.

Review alt distribution records and complaints reported in Country Y.

Prepare the legal team in Country Y for possible litigations.

NEW QUESTION 43
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?

Inform the regulatory authorities.

Delay the start of product production.

Correct the label text.

Abort the product launch.

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The regulatory affairs industry is a critical part of the healthcare sector that ensures the safety and efficacy of medical products. The regulatory affairs professionals are responsible for navigating the complex regulatory landscape and ensuring that all products meet the required standards before they are released to the market. The regulatory affairs professionals play a vital role in ensuring that the healthcare products undergo rigorous testing and are safe for use by patients. One way to demonstrate proficiency in regulatory affairs is by obtaining the Regulatory Affairs Certification (RAC) US certification.

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