Category 1 Focus Group

PART OF CROSS COMPANY ABUSE LIABILITY COUNCIL (CCALC)

 

ABOUT THE GROUP

The Category focus group was formed in spring 2015

 

 

 

 

 

 

 

 

 

 

Founder of the Cat 1 focus group and Member of the board of the Cross Company Abuse Liability Council (CCALC)

Karsten Lindhardt, Ph.D MSc DBE

CSO at Egalet Cooperation.

 

Focus Group Charter

• 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

 

If you have questions, please contact

Torben Elhauge

Egalet CoRperation

telhauGE@egalet.com