Free RAPS RAC-GS Exam Dumps Questions & Answers

The manufacturer of an API was changed from Company X to Company Y during the late stage of a new drug development. Despite differences in the manufacturing processes of the companies, both APIs meet the current specifications. Which is the MOST appropriate information to include in the final submission documents?

• A.The process information and analytical result of Company Y API
• B.Information deemed appropriate by the regulatory authority
• C.The process information and the comparative analytical result of APIs from both companies
• D.The process information and analytical result of Company X API

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

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

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.File a report to regulatory authorities and advise the marketing department to prevent future off-label use.
• B.Discuss with regulatory authorities to investigate how to have the off-label indication approved.
• C.No action is required since it is an off-label use.
• D.Advise the senior management to send a "Dear Dr." letter.

After submission to the regulatory authority, a substantial error was found in the application. In order to resolve this issue, what should be done FIRST?

• A.Verify the procedure in the regulation for the corrections.
• B.Resubmit the entire package.
• C.Inform upper management immediately.
• D.Contact the legal department and ask them how to proceed.

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