Best Practices in Clinical Practice Guideline Development

Developing clinical practice guidelines (CPGs) for controlled substances requires balancing scientific rigor, clinical practicality, and patient-centered care. In June 2025, the Reagan-Udall Foundation for the FDA, in collaboration with FDA, convened five FDA-funded research teams, federal partners, and guideline developers to explore how to strengthen these efforts—from addressing evidence gaps to improving stakeholder engagement, dissemination, and implementation. The report summarizes key insights on developing clinical practice guidelines involving controlled substances and explores strategies for addressing evidence limitations, engaging stakeholders, and improving communication and implementation.