NO.1 In the process of obtaining a product approval, a regulatory affairs professional discovers that
does not meet one of the specific technical requirements of the regulation. However, competitors
substantially similar products have claimed compliance with the requirement and received approval.
Which action should the regulatory affairs professional take FIRST?
A. Inform the internal departments to redesign the product to comply with this requirement.
B. Discuss with the regulatory apriority and attempt to reach an acceptable solution.
C. Notify senior management that the product cannot be registered.
D. Inform the regulatory authority that such a requirement is not applicable to the product.
NO.2 Which of the following double-blind clinical trial designs would be MOST appropriate for a
Phase III study
with a new product intended to treat an acute life-threatening disease with less than optimal
NO.3 Who has the PRIMARY responsibility for recall of products with quality defects?
A. Regulatory authority
NO.4 As part of the regulatory strategy for companies intending to manufacture a psychotropic
of the following approvals should be received FIRST?
A. Import license
B. Export license
C. Site license
D. Product license
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