The beginning of the second Trump administration has been marked by significant—and often sudden—efforts to shrink the federal workforce and replace agency leadership to establish and deliver on a new set of priorities. In the past weeks, the administration has pursued a deferred resignation program,[1] terminated employees both in leadership and on probationary status,[2] and announced plans for a forthcoming government-wide reduction in force.[3] The U.S. Food and Drug Administration (FDA) has not been immune to these changes.
Life Sciences 2025 Outlook
The life sciences industry is entering 2025 with a largely favorable set of catalysts for the coming year, but also with some larger risks that will impact companies differently.
FDA to Require Confirmatory Trials Be “Underway” Prior to Accelerated Approval, Per New Draft Guidance
Life sciences companies interested in pursuing accelerated approval should ensure they have a thorough understanding of the complex regulatory landscape and engage in early discussions with FDA regarding their drug development programs.
FDA Issues Overdue Guidance on Diversity Action Plans in Drug and Device Clinical Trials – What You Need to Know
This update provides key takeaways on the new draft guidance and Diversity Action Plan requirements, including when the new requirements will go into effect, the types of clinical studies that require submission of a Diversity Action Plan, whether FDA intends to issue waivers for the requirements, and the consequences of failure to submit a Diversity Action Plan.