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.Notify the regulatory authority regarding Its obligation to honor the commitment to approve the
  application.
• B.Review the regulatory guidelines to determine how to proceed.
• C.Request a meeting with the regulatory authority to discuss the application.
• D.Consult with the legal department to discuss the best course of action.

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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.International import and export regulations
• B.The time frame in which the patent will expire
• C.Doha Declaration in the TRIPS Agreement
• D.The stability of the drug in all zone conditions

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An inspection of a manufacturing site determines that a number of manufacturing changes have been
implemented without obtaining the necessary regulatory clearance. Which of the following actions should
the regulatory affairs professional complete FIRST?

• A.Stop product manufacturing.
• B.Review the stability data for the changes.
• C.Assess the impact of the changes.
• D.Establish validation procedures.

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

• A.Deleting a drug substance
• B.Strengthening a precaution to the product labeling
• C.Introducing a new analytical method
• D.Deleting an ingredient of the drug product

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Which of the following claims would classify an apple as a drug?

• A."It will satisfy hunger."
• B."It will prevent colds."
• C."It will whiten teeth."
• D."It will make you look younger."

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