Regulatory Affairs Certification (RAC) US
Last Update 5 days ago
Total Questions : 100
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According to WHO, what are the temperature and humidity conditions for a Zone IVb long-term stability study?
Company X encounters challenges in the global life cycle management of its medical devices. Which of the following Is MOST appropriate for improving product life cycle management?
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 drug product presents degradation during the manufacturing process. In addition to the amount, what information should be provided FIRST in order to use API overage?
A company is developing a novel drug to combat AIDS. The preliminary results are very promising and include instances of complete remission. The company has been granted patents in multiple countries for the drug. The regulatory affairs professional is asked to prepare a brief report concerning potential problems for marketing of the product worldwide. Which of the following is the MOST important consideration to discuss?
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 company is developing a new medical device. During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?
GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation based on which of the following?
A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?
A clinical study of a drug is completed to support a marketing approval application. According to ICH, how long should a sponsor retain the clinical study essential documents?
SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following?
According to ICH, which of the following components of study information is NOT required in a clinical study report?
A global company has obtained a patent in a specific country for a newly marketed product. What would be the BEST advice In order to protect the patent in other countries?
TESTED 30 Sep 2023
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