Slides

Abuse Deterrent Formulation Science Meeting 

Discussion of the FDA Draft Guidance for Industry: Abuse Deterrent Opioids – Evaluation and Labeling

 

  • 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 

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)


VI. Postmarketing Studies (Categories 4)



VII. Drug Labeling



VIII. Additional Research Needs (Generics)






IX. Summary