FDA Regulatory Submissions: Challenges, Trends, and Future Predictions

Edye Edens from KLF offers a brief yet in-depth overview of FDA regulatory submissions for clinical research in the U.S., reflecting on both current practices and predictions for 2025. She highlights how AI tools and evolving political dynamics are shaping the regulatory landscape, emphasizing that while efficiency improvements are necessary, careful and strategic approaches are critical to maintain the FDA’s global reputation and safety standards. Edye discusses the complexity of submissions...