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 like Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications, noting the significant preclinical work, detailed documentation, and thorough FDA review process involved. She also underscores the global weight of FDA approvals, as many international regulatory bodies rely on FDA assessments as a benchmark.

Finally, Edye poses key questions to her audience:

• How familiar are you with regulatory submissions?
• Are you considering outsourcing this complicated process?
• Where do you see opportunities for efficiency—through AI, technology, or administrative changes?
• If you’ve been a reviewer, how do you balance efficiency with safety?

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