In response to a regulatory authority's change of mind about product approval, what should the company do?

When faced with a situation where a regulatory authority has changed its stance on product approval, the most proactive approach is to request a meeting with the regulatory authority to discuss the application. This step is critical for several reasons.

Engaging directly with the regulatory authority allows the company to gain a clearer understanding of the reasons behind the change in decision. It provides an opportunity to communicate any concerns, clarify any misunderstandings, and foster dialogue which can lead to a better resolution. By opening a line of communication, the company can present its case, provide additional data or information if necessary, and address any issues that may have influenced the regulatory authority's decision.

This approach can also demonstrate the company's commitment to maintaining regulatory compliance and its willingness to cooperate with the authorities. Additionally, a meeting can facilitate discussions on potential next steps or alternatives that could lead to a favorable resolution, which might not be achievable through written communication alone.

In contrast, while notifying the regulatory authority of obligations, consulting with the legal department, or reviewing guidelines are important processes, none of these actions directly addresses the immediate need for dialogue and clarification on the change in decision. These may be essential steps following the meeting, but initiating direct contact is typically the most effective strategy when confronted with regulatory uncertainties.