RAC-GS 무료 덤프문제 온라인 액세스

The safety database for an anti-hypertensive drug consists of the following:
461 patients exposed for three months
343 patients exposed for six months
112 patients exposed for nine months
74 patients exposed for 12 months
Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?

• A.500 patients for three months
• B.200 patients for nine months
• C.3.000 total patient exposures
• D.100 patients for 12 months

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

During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic.
What should be done in response to identifying the impurity?

• A.Perform both identification and non-clinical qualification studies concurrently.
• B.Perform either an identification study or a non-clinical qualification study.
• C.Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.
• D.Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.

A global company is developing a sophisticated implantable medical device that is coated with antibiotics and biologics to enhance its efficacy. The product is marketed in Country X.
where it is regulated as a medical device. The same product, without theantibiotics and biologics, is marketed as a medical device in Country Y.
The company is proposing to start marketing the coated device in Country Y.
Which regulatory approach should the company propose?

• A.E. Examine decisions made about similar products in Country Y to propose the classification ofthe product.
• B.Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.
• C.Submit the product for review as a pharmaceutical product in Country Y.
• D.Apply for review of the additional part of the product as a pharmaceutical product in Country

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.Guidance documents for the device
• C.Determination of primary mode of action
• D.Determination of product design deliverables