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. Consult with the legal department to discuss the best course of action.

C. Review the regulatory guidelines to determine how to proceed.

D. Request a meeting with the regulatory authority to discuss the application.

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.

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?

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

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

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

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

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

A. Instructions for use

B. Risk analysis

C. Product literature

D. Essential principles

Which of the following BEST describes the content of the "Physical, Chemical, and Pharmaceutical Properties and Formulation" section of an IB?

A. A review of available data to support the determination of the chemical structure and physical attributes of the drug substance plus batch analysis and stability data for the finished formulation

B. A detailed summary of the physical and chemical properties of the drug product with a signed expert statement addressing the suitability and stability of the formulation for its intended use

C. A description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product

D. A brief summary of relevant physical, chemical, and pharmaceutical properties: instructions for storage and handling of the dosage form: and a description of the formulation