Abuse Deterrent Formulation Science Meeting 

Discussion of the FDA Draft Guidance for Industry: Abuse Deterrent Opioids – Evaluation and Labeling


VI. Postmarketing Studies (Categories 4)

VII. Drug Labeling

VIII. Additional Research Needs (Generics)

IX. Summary

I. Welcome and Opening Remarks  

II. Keynote


III. Background

IV. Laboratory Manipulation and Extraction Studies (Category 1)

V. Pharmacokinetic (Category 2) and Clinical Abuse Potential Studies

(Category 3)

  • Organized by the Cross Company Abuse Liability Consortium (CCALC)

  • Facilitated with the aid of the College on Problems of Drug Dependence (CPDD)

  • With presentations by the FDA representatives