The Best RAC-US Exam Study Material Premium Files and Preparation Tool (Feb-2023) [Q56-Q78]

NO.56 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.57 A materials supplier informs a company that it intends to stop supplying a material critical to the manufacture of the company’s products. What action should the company take FIRST?

NO.58 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?

NO.59 SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following?

NO.60 Company X has a patent for an anti-inflammatory drug that will expire in one year. In order to minimize the effect of the patent expiration, which is the BEST action for the company to take?

NO.61 During an audit of a contract manufacturing facility by a potential client, the auditor requested to be left alone in the records room. The records room contains information on all products produced by the contract manufacturer.
Which action is MOST appropriate for the regulatory affairs professional to take?

NO.62 According to the ICH guideline on GMP for API, to which of the following is the MOST stringent requirement applied?

NO.63 Which of the following claims would classify an apple as a drug?

NO.64 Which of the following is MOST appropriate for the purpose of lot release of biologics?

NO.65 Which question is pertinent to demonstrate a new pharmaceutical’s effectiveness during evaluation by a reimbursement agency?

NO.66 A regulatory authority announces an inspection of a regulatory affairs professional’s facility during a holiday season when most of the staff Is not available. What is the MOST practical approach to this dilemma?

NO.67 Company X and Company Y both have products for the treatment of rare genetic diseases.
Company X would like to acquire Company Y but does not know enough about Company Y to make an offer.
What is the MOST appropriate approach that Company X should take to acquire more information about Company Y?

NO.68 Following the introduction of a new regulation, an evaluation of the company’s products by the regulatory affairs professional indicates that 60 percent do not comply with the regulation.
What should the regulatory affairs professional do FIRST to meet the new requirement?

NO.69 A company’s product was approved by a regulatory authority with the condition that further studies must be completed prior to full approval of the product.
To minimize product-associated risk to patients during the period of conditional approval, what is the LEAST effective way to achieve this goal?

NO.70 Which of the following is the PRIMARY purpose of an audit report?

NO.71 According to ICH, what is the MAXIMUM amount of time in calendar days that an organization has from the initial receipt of information to report serious and unexpected ADR of a marketed product to regulatory authorities?

NO.72 Which of the following BEST describes the process of post-marketing surveillance for healthcare products?

NO.73 In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation.
However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?

NO.74 Why is it necessary to run supplemental safety pharmacology studies?

NO.75 Which of the following double-blind clinical trial designs would be MOST appropriate for a
Phase III study with a new product intended to treat an acute life-threatening disease with less than optimal available therapy?

NO.76 During face-to-face meetings with the regulatory authority to address submission issues, what is the BEST choice for the number of company representatives who should attend?

NO.77 What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?

NO.78 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 the antibiotics 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?