What is the best course of action for a regulatory professional negotiating product labeling with the FDA?

The best course of action for a regulatory professional negotiating product labeling with the FDA is to negotiate with the review division. Engaging in negotiation directly with the review division allows for a collaborative approach where the regulatory professional can discuss the concerns, requirements, and expectations regarding the product labeling. This division typically possesses the most relevant expertise and insight into the specifics of the labeling requirements and helps to ensure that the discussion is tailored to the product at hand.

Negotiating offers an opportunity to clarify any misunderstandings, propose alternatives, and ultimately work towards achieving labeling that complies with regulatory standards while meeting the product's marketing needs. This is a constructive process that can lead to an efficient resolution, ultimately paving the way for smoother regulatory approval.

The other options, while they may appear viable at first glance, do not facilitate the same level of direct communication and negotiation that can occur with the review division, potentially leading to less favorable outcomes for product labeling.