New Insights Into FDA Meetings

Cultivating a strong partnership with the U.S. Food and Drug Administration (FDA) is a pivotal element of a successful product development strategy for sponsors introducing innovative drugs, biologics, or devices to the market. The FDA offers various opportunities for engagement and guidance throughout the development process. These interactions enable sponsors to educate the Agency about their products and strategies, receive input on available data, address evolving regulatory requirements, and pinpoint potential plan gaps. Such exchanges are especially invaluable for de-risking complex product development and novel therapeutic targets.

Recognizing the critical importance of sponsor-FDA interactions, it is crucial to invest in meticulous preparation and strategic planning. Knowing when and how to engage with the FDA significantly impacts a product's ultimate success. To facilitate this process, the FDA has issued guidance documents outlining formal meeting types between sponsors and the Agency.

Halloran has extensive experience in leading or supporting approximately 22 formal meetings with the FDA annually. We can take the lead in crafting regulatory strategies, preparing documentation, and orchestrating FDA discussions, or we can serve as a secondary expert to review your strategy—offering a flexible range of services to assist you.

Let us be your guide in this endeavor.