Bryan Cave's FDA team has considerable experience reviewing all types of FDA marketing applications for compliance with FDA regulations. We have drafted and collaborated on applications with clients short on manpower, time, or specific knowledge. During the review process, we work directly with the FDA reviewing division to ensure the filings are reviewed in as timely a manner as possible, and that any substantive issues raised by the reviewers are resolved promptly. We also routinely have access to and work with a wide network of consultants (e.g., medical experts, pharmacologists/toxicologists, regulatory chemists, engineers, software experts, investigators) when the need arises.

We prepare our clients for guidance meetings, and meetings with FDA advisory committees that are reviewing their applications. In the event FDA seeks to impose conditions on a marketing approval, the team has experience crafting post-market surveillance studies, labeling revisions, and completing other projects to ensure those conditions are met. We also have significant experience helping clients secure user fee reductions or waivers.