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?

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?

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

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 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?