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?
- Contact the regulatory authority to argue that its conclusions are wrong.
- Contact the regulatory authority to discuss its findings.
- Repeat the Hepatotoxicity tests and send the results to the regulatory authority.
- Wait for the regulatory authority's final publication on its findings.