Category 1 Focus Group

Part of the Cross Company Abuse Liability Council (CCALC)


  •  To share experiences and best practices in in vitro (Category 1) assessments of abuse deterrent formulations
  • To discuss standardization of in vitro (Category 1) studies and limits associated with established standard practices
  • To provide an open forum for discussion on the FDA Guidance for Industry: Abuse Deterrent Opioids – Evaluation and Labeling
  • To provide an opportunity for presentations by academia, regulatory and industry experts focused on Category 1 studie



Testing abuse deterrent properties of opioid formulations is a relatively new discipline. Guidelines for evaluation of abuse deterrent properties of branded was issued by the FDA in 2015. A guideline for evaluating abuse deterrent properties of generic products was issued in November 2017. Different stages of testing including in vitro tests (Category 1) and clinical human abuse liability studies (Category 2 &3) were identified as critical parts of the evaluation. Due to the very different nature of the Category 1 studies relative to the clinical studies, it was decided to initiate a focus group with people involved in Category 1 testing in order to have a forum where the study protocols, testing and interpretation of these data could be discussed. The group and meetings includes people from FDA, Academia and Industry including specialist consultants in Category 1 testing. This group is now part of the CCALC umbrella organization and is currently headed by Karsten Lindhardt and Sebastian Schwier. The meetings are organized by a steering committee. 



1st Meeting

First meeting was focused around the FDA guidance "Abuse Deterrent Opioids, Evaluation and Labeling -

 Guidance for Industry "


2nd Meeting

The second meeting was focused around  the FDA Guidance "General Principles for Evaluating the Abuse Deterrence of  Generic Solid Oral Opioid Drug Products Guidance for Industry, November 2017" 

3rd Meeting

The third meeting was focused around standardization of Cat 1 testing and the  product specific guidelines.

4th Meeting

Was held  June 4-5, 2019 in the Wasington area. The meeting focused on recent trends, the generic guideline, safety of excipients, and future developments within Cat 1 testing.

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The 4th meeting took place on 4-5 June 2019

Category 1 Focus Group