Human Abuse Potential: CSS Interactions

Evaluating the abuse potential of CNS‑active drugs is a critical component of drug safety and regulatory readiness. Regulatory expectations in this area continue to evolve, making early and ongoing engagement with the FDA’s Controlled Substances Staff (CSS) an essential part of development strategy. Proactive consultation—beginning as early as the pre‑IND stage—helps sponsors identify potential abuse‑related signals, align nonclinical and clinical plans with FDA expectations, and avoid costly missteps later in development. Thoughtful collaboration with CSS becomes even more important as programs advance, particularly when human abuse potential studies are required. Early review of study protocols and statistical analysis plans ensures that key design elements, controls, and methodologies are fit for purpose and acceptable to regulators.

Learn how, by embedding FDA engagement into the development process, sponsors can strengthen their abuse potential assessment and support smoother regulatory review.