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                     RAPS RAC-US Dumps PDF
Regulatory Affairs Certification (RAC) US
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Question: 1 
 
A superiority advertising claim for a product versus its competitor's product can only be made under 
which of the following circumstances? 
 
A. In vitro studies show the product to be superior. 
B. Government survey data indicate the product is superior. 
C. Results of a three-year, post-market patient survey indicate the product is superior. 
D. Results of adequate, well-controlled comparative clinical trial show the product is superior. 
 
Answer: D 
 
Question: 2 
 
A regulatory affairs professional is asked to review and update regulatory affairs SOPs. Which aspect of 
the SOP Is MOST important to consider? 
 
A. Expiration date 
B. Relevance to regulations 
C. Revision history 
D. Scope and level of detail 
 
 
Answer: B 
 
Question: 3 
 
Which term does NOT describe the same concept as the others? 
 
A. Biosimilars 
B. Follow-on protein products 
C. Monoclonal antibody 
D. Subsequent entry biologics 
Answer: C 
 
Question: 4 
 
A company is developing a new product for the global market. A new international guideline will 
recommend relevant studies in the pediatric population, and the guideline will be effective before the 
approval of the company's new product. 
 
What is the BEST advice the regulatory affairs professional can provide to minimize the impact of this 
guideline on the successful registration of the new product? 
 
A. The company should consult with relevant regulatory authorities to determine the potential impact 
on the current registration plan. 
B. The new guideline has no impact on the current registration plan, but the company must be prepared 
to defend its decision. 
C. The new guideline has no impact on the current registration plan since all relevant registration studies 
are almost completed. 
D. The company should initiate the required pediatric studies immediately to avoid costly delays to the 
current registration plan. 
 
Answer: A 
 
Question: 5 
 
SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the 
following? 
 
A. Inadequate training 
B. Late and/or incorrect deliverables 
C. Causes of non-conformities 
D. Adverse environmental impacts 
 
 
Answer: C 
 
Question: 6 
 
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. Label the product for use in appropriate populations. 
B. Educate patients and healthcare providers on how to use the product 
C. Delay product launch until required studies are completed. 
D. Promote off-label use to a carefully selected patient population. 
 
 
Answer: D 
 
 
Question: 7 
 
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 
 
Question: 8 
 
A company is considering the development of a medical device similar to those already available. Which 
of the following should be evaluated FIRST when developing a clinical evaluation document? 
 
 
A. Adverse event reports 
B. Clinical experience 
C. Clinical investigations 
D. Literature search 
 
Answer: C 
 
Question: 9 
 
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. Three years after the last clinical study site was supplied with investigational drugs 
D. Until the product has been discontinued from marketing in all ICH regions 
 
 
Answer: A 
 
 
Question: 10 
 
The regulatory authority contacts the regulatory affairs professional regarding a complaint about a drug 
produced by the company. A consumer reported to the regulatory authority that the tablets have a 
slightly different color and break easily. 
Which of the following actions should the regulatory affairs professional take? 
 
A. Ask that the regulatory authority provide the batch number printed on the packaging of the affected 
product. 
B. Ask that the regulatory authority provide the actual product subject to the complaint. 
C. Respond to the regulatory authority that the product subject to the complaint is most likely a 
counterfeit product. 
D. Respond to the regulatory authority that the company will provide copies of the relevant QC records 
for batch release. 
 
Answer: A