QUESTION 19
Who has the PRIMARY responsibility for recall of products with quality defects?

QUESTION 20
Which of the following claims would classify an apple as a drug?

QUESTION 21
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?

QUESTION 22
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?

QUESTION 23
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?

QUESTION 24
A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?

QUESTION 25
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?

QUESTION 26
Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?

QUESTION 27
At a recent scientific meeting, Company Y had two booths:
* At one booth, Company Y provided brochures on a completed Phase II study.
* In an adjacent booth, Company Y’s sales professionals were promoting one of Company
Y’s marketed products.
A regulatory affairs-professional at Company X sends a letter to a counterpart at Company
Y requesting that Company Y stop this practice in the future and demanding a formal response to the letter. How should the regulatory affairs professional at Company Y BEST respond?

QUESTION 28
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?

QUESTION 29
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?

QUESTION 30
Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?

QUESTION 31
You discover that your company’s top selling product in the last two years has been used off-label.
The off-label use is estimated to be about 70%, and it has been consistent since the product was first released to the market. Which of the following is MOST appropriate?

QUESTION 32
According to ICH, which of the following components of study information is NOT required in a clinical study report?

QUESTION 33
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?

QUESTION 34
A company is developing a line of products for which no ISO standard of performance is available. As a result, the company wishes to propose developing such a standard. Whom should the company contact in order to start the development of the new standard?

QUESTION 35
Why is it necessary to run supplemental safety pharmacology studies?

QUESTION 36
What is the LAST stage in the development of a quality risk management process for a medical device?

QUESTION 37
A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?

QUESTION 38
Which of the following is MOST appropriate for the purpose of lot release of biologics?

QUESTION 39
Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication?

QUESTION 40
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?

QUESTION 41
During a routine review of promotional materials for a product, a regulatory affairs professional discovers an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory affairs professional to take?

QUESTION 42
A process is ultimately validated to ensure which of the following?