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NEW QUESTION 34
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?

A. Phase I clinical trialsB. Phase I and II clinical trialsC. Phase III clinical trialsD. Pre-clinical studies

Answer: C

 

NEW QUESTION 35
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 a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.D. Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.

Answer: D

 

NEW QUESTION 36
The regulatory authority contacts the regulatory affairs professional regarding a complaint about a drug produced by the company. A consumer reported to the regulatory authority that the tablets have a slightly different color and break easily.
Which of the following actions should the regulatory affairs professional take?

A. Ask that the regulatory authority provide the batch number printed on the packaging of the affected product.B. Ask that the regulatory authority provide the actual product subject to the complaint.C. Respond to the regulatory authority that the company will provide copies of the relevant
QC records for batch release.D. Respond to the regulatory authority that the product subject to the complaint is most likely a counterfeit product.

Answer: A

 

NEW QUESTION 37
During routine surveillance, a regulatory authority sent a company the following communication: "Hepatotoxicity and suicidal behavior were identified as potential safety issues for the company's product. The regulatory authority is evaluating these issues to determine the need for any regulatory action." Which action would be the most appropriate
FIRST step for the company to take?

A. Contact the regulatory authority to discuss its findings.B. Wait for the regulatory authority's final publication on its findings.C. Repeat the Hepatotoxicity tests and send the results to the regulatory authority.D. Contact the regulatory authority to argue that its conclusions are wrong.

Answer: A

 

NEW QUESTION 38
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