After receiving a commitment from a regulatory authority, what should a company do if the authority expresses doubt about product approval?

When a regulatory authority expresses doubt about product approval, it is crucial for the company to engage directly with the authority to clarify any uncertainties surrounding the application. Requesting a meeting provides an opportunity for the company to understand the specific concerns of the regulatory authority in detail. This discussion can help identify any gaps in the application or additional data needed to support the product’s approval. Open communication is vital in regulatory affairs as it not only helps in addressing doubts but also fosters a collaborative relationship between the company and the regulatory body.

Engaging in a dialogue allows the company to articulate its position more effectively and potentially address any misunderstandings or provide further justification for their product. Such proactive steps are essential for navigating the regulatory landscape effectively and can significantly enhance the chances of achieving product approval.