RAC-US Online Practice Questions and Answers

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

A. "Product X is a guaranteed cure for arthritis."

B. "Product X is effective for the treatment of arthritis."

C. "Product X is safe for arthritis and without side effects."

D. "Product X is effective in all patients with arthritis."

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. Withdraw the affected product from the markets.

B. Send a "Dear Dr." letter to customers.

C. Notify the global regulatory authorities.

D. Assess the potential safety risk.

In preparation for the development of a new line of products, a regulatory affairs professional is asked to prepare a short presentation for senior management. Which of the following topics is MOST important to cover?

A. Potential clinical sites for the Phase III clinical trial

B. Regulatory requirements for labeling and packaging

C. Capacity of the manufacturing facilities to fully produce the new product

D. Previous actions taken by regulatory authorities on similar products

Following the introduction of a new regulation, an evaluation of the company's products by the regulatory affairs professional indicates that 60 percent do not comply with the regulation.

What should the regulatory affairs professional do FIRST to meet the new requirement?

A. Contact the trade association for advice.

B. Communicate with the relevant internal departments.

C. Prepare documents for the files.

D. Request a permanent waiver from the new regulation.

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. Before the enactment of the regulation, through the industry representative

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

C. After the enactment of the regulation, through the industry representative

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

You discover that your company's top selling product in the last two years has been used off-label. The off-label use is estimated to be about 70%, and it has been consistent since the product was first released to the market. Which of the following is MOST appropriate?

A. Discuss with regulatory authorities to investigate how to have the off-label indication approved.

B. No action is required since it is an off-label use.

C. Advise the senior management to send a "Dear Dr." letter.

D. File a report to regulatory authorities and advise the marketing department to prevent future off-label use.

A company is preparing the submission package for a drug to be registered in international markets. When preparing the legal documentation, which document MUST comply with the WHO recommendations?

A. Certificate of GMP

B. Certificate of Free Sale

C. Certificate of Pharmaceutical Product

D. Certificate of Analysis for the finished product

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

According to ICH, how many stability time points are normally required to establish a two- year shelf life for a product?

A. 3

B. 5

C. 7

D. 9

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

A. Volume and material

B. Compatibility and safety

C. Safety and efficacy

D. Efficacy and material

A company is developing a novel drug to combat AIDS. The preliminary results are very promising and include instances of complete remission. The company has been granted patents in multiple countries for the drug. The regulatory affairs professional is asked to prepare a brief report concerning potential problems for marketing of the product worldwide. Which of the following is the MOST important consideration to discuss?

A. Doha Declaration in the TRIPS Agreement

B. The stability of the drug in all zone conditions

C. The time frame in which the patent will expire

D. International import and export regulations

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

B. Initiate a mandatory recall of the product in Country Y.

C. Review alt distribution records and complaints reported in Country Y.

D. Prepare the legal team in Country Y for possible litigations.

Which of the following is NOT required to be included in a marketing application?

A. Final printed label

B. Quality, safety, and efficacy Information

C. Administrative forms

D. Evidence of fee payment

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.

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?

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

B. Insist that key personnel be available for the inspection.

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

D. Arrange for an inspection without all intended personnel.