One month prior to the anticipated approval date for your product, the marketing application that you submitted to a major regulatory authority has become the subject of an advisory committee meeting of experts convened by the regulatory authority. The advisory committee members unanimously vote not to approve your product because of a safety concern. Two days after the advisory committee meeting, the regulatory authority requests additional information to support the safety of your product. Assuming you have no additional data to provide, which of the following would be your MOST appropriate response to the regulatory authority's request?

• A."We have no additional information to provide at this time, but we can perform an additional analysis for a specific safety concern, if necessary."
• B."We disagree with the advisory committee's decision because the committee neglected the thorough safety analysis that we provided."
• C."Given the advisory committee's unanimous decision, we know that the product will not be approved, and additional data will not make any difference."
• D."We have no additional information to provide at this time because we have already provided everything needed to support our product's approval."

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Which term does NOT describe the same concept as the others?

• A.Subsequent entry biologics
• B.Monoclonal antibody
• C.Biosimilars
• D.Follow-on protein products

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According to ICH, which of the following components of study information is NOT required in a clinical study report?

• A.Randomization scheme and codes
• B.Detailed CV of all investigators
• C.Protocol and protocol amendments
• D.List of lECs or lRBs

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A request was received from a regulatory authority asking the company to conduct product testing in compliance with a newly issued regulation.
What should be done. What action should the company take FIRST?

• A.Contact the regulatory authority that issued this request and discuss the requirement.
• B.Consult with colleagues about the request.
• C.Send a letter back to the regulatory authority indicating why the regulation does not apply to the product.
• D.Initiate testing immediately to ensure compliance.

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A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?

• A.Product distribution
• B.Plasma pooling
• C.Individual plasma donation
• D.Plasma fractionation

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