NO.23 The requirements for document control are located in which of the following documents?

NO.24 When applying for marketing approval of a drug for a rare disease, which requirement can be waived?

NO.25 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?

NO.26 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?

NO.27 What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?

NO.28 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?

NO.29 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?

NO.30 A superiority advertising claim for a product versus its competitor’s product can only be made under which of the following circumstances?

NO.31 One month prior to the anticipated approval date for your product, the marketing application that you submitted to a major regulatory authority has become the subject of an advisory committee meeting of experts convened by the regulatory authority. The advisory committee members unanimously vote not to approve your product because of a safety concern. Two days after the advisory committee meeting, the regulatory authority requests additional information to support the safety of your product. Assuming you have no additional data to provide, which of the following would be your MOST appropriate response to the regulatory authority’s request?

NO.32 Which term does NOT describe the same concept as the others?

NO.33 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?

NO.34 Company X has a patent for an anti-inflammatory drug that will expire in one year. In order to minimize the effect of the patent expiration, which is the BEST action for the company to take?

NO.35 According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?

NO.36 Which of the following claims would classify an apple as a drug?

NO.37 Which question is pertinent to demonstrate a new pharmaceutical’s effectiveness during evaluation by a reimbursement agency?