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Download Regulatory Affairs Certification (RAC) US Exam Dumps
NEW QUESTION 52
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 company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.
- D. Contact the local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.
Answer: A
NEW QUESTION 53
Company X is planning to acquire the rights for a product marketed by Company Y.
As part of due diligence, what is the MOST important information the Company X regulatory affairs professional should ask senior management to request from Company Y?
- A. Marketing materials
- B. Intellectual properly
- C. Safety issues
- D. Clinical trial data
Answer: C
NEW QUESTION 54
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. Establish validation procedures.
- B. Assess the impact of the changes.
- C. Review the stability data for the changes.
- D. Stop product manufacturing.
Answer: D
NEW QUESTION 55
SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following?
- A. Inadequate training
- B. Causes of non-conformities
- C. Late and/or incorrect deliverables
- D. Adverse environmental impacts
Answer: B
NEW QUESTION 56
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
Answer: D
NEW QUESTION 57
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