NO.58 At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?

NO.59 What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?

NO.60 Which of the following statements regarding the off-label use of drugs is CORRECT?

NO.61 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?

NO.62 A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for review and approval. The regulatory authority issues the company a written commitment that if the studies are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre- specified criteria, the company receives a letter from the regulatory authority stating that it no longer believes that the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?

NO.63 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?

NO.64 Which term does NOT describe the same concept as the others?

NO.65 According to ICH, which of the following components of study information is NOT required in a clinical study report?

NO.66 In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?

NO.67 Under which of the following circumstances would a regulatory authority require a more detailed premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data than would normally apply to an IVD device of that risk class?

NO.68 According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?

NO.69 Which of the following BEST describes the process of post-marketing surveillance for healthcare products?

NO.70 During the review of a design dossier, the reviewer asks why the company has only carried out a top-down risk approach. The reviewer is referring to which of the following?

NO.71 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?

NO.72 The requirements for document control are located in which of the following documents?

NO.73 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?

NO.74 Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?

NO.75 Which of the following is the MOST desirable timing and approach for a regulatory affairs professional who wants to provide feedback on proposed new regulations?

NO.76 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?

NO.77 According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?