When negotiating with the FDA on a product's final labeling, what is the regulatory professional's best course of action if the FDA proposes a more restrictive claim?

Negotiating with the FDA regarding a product's final labeling is a critical aspect of regulatory affairs, especially when faced with a proposal for a more restrictive claim. The best course of action in this situation is to negotiate with the review division. Engaging in negotiation allows the regulatory professional to present scientific data, clinical evidence, and arguments that support the desired labeling claims. This dialogue is essential in addressing concerns the FDA may have while aiming to reach a compromise that satisfies both parties.

Establishing a clear line of communication with the review division enables the regulatory professional to understand the rationale behind the FDA's position and, equally important, to advocate effectively for the proposed claims based on the product's benefits, intended use, and supporting evidence. This proactive engagement can lead to potential adjustments in the FDA's proposal and can foster a collaborative relationship between the sponsor and the regulatory authority.

While accepting the FDA's proposed labeling is an option, it does not utilize the opportunity for dialogue and collaboration that could lead to a more favorable outcome. Contacting the center's director or the ombudsman may be viable if negotiations fail or significant issues arise, but they are typically not the best first steps in addressing specific labeling negotiations. Engaging directly with the review division maintains focus on the