RAC-GSRegulatory Affairs Certification (RAC) Global Scope
100 Questions and Answers Experienced specialists selected 100 questions for this exam. All answers are verified to ensure correctness.
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RAC-GS Online Practice Questions and Answers
A company receives multiple complaints regarding the text included on a recently launched product's label. What action should the regulatory affairs professional take FIRST?
A. Recommend an immediate product recall.
B. Compare the approved text with the product label
C. Notify the regulatory authority.
D. Inform the production team.
A company is developing a device-drug combination product. Which of the following should be evaluated FIRST in order to determine the applicable guidance documents?
A. Approved indications of the drug
B. Determination of primary mode of action
C. Determination of product design deliverables
D. Guidance documents for the device
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. Establish validation procedures.
C. Assess the impact of the changes.
D. Review the stability data for the changes.
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