What Global Companies Need to Know About Navigating FDA Regulations and U.S. Market Entry

In this episode, Mike Burke, AGG Corporate partner and co-chair of the firm’s International Initiative, is joined by Alan Minsk, AGG Food & Drug chair, to unpack the intricacies of working with the Food and Drug Administration ("FDA"). Mike and Alan dive into common mistakes companies make when engaging with the agency and highlight the importance of preparation and strategic timing. They also discuss challenges concerning cross-border approvals, customs, and diverse regulatory systems worldwide.