Category 1 Focus Group

Bob Bianchi participated in the third, category 1 focus group meeting in Old Town Alexandria VA, January 30 & 31, 2018. The charter for the meeting included; sharing experiences and in vitro best practices of assessing abuse deterrent formulations, standardization of in vitro  studies, providing an open forum for discussion on the FDA guidance documents for  branded and generic formulations, and to provide an opportunity for presentations by academia, regulatory and industry experts focused on Category 1 studies. Bob co-chaired a working group discussion on analytical considerations.