Regulatory Submissions, Information, and Document Management Forum

Over the past year, the U.S. Food and Drug Administration (FDA) has continued its modernization efforts, implementing significant changes in regulatory processes and technological advancements to enhance efficiency, transparency, and compliance in regulatory submissions. This session will provide a comprehensive review of key FDA updates and notable FDA guidance documents issued over the past year. Additionally, emerging trends, regulatory shifts, and insights that have shaped the FDA’s approach to regulatory submissions and information management will be discussed.