FDA recently announced the initiation of a pilot program for QbD submissions for biotech products. While this has been viewed positively, it has also generated some concern within biotechnology companies on the exact nature of submissions that the FDA is expecting as part of this pilot, and the potential regulatory relief that companies may obtain upon submission of the documents. The intent of this session to have an update from the agency on the types of submissions it has received as well as potential case studies from companies on the data that is being submitted to obtain regulatory relief.

• FDA update on QbD pilot program submissions
• Industry case studies on QbD submissions
• Update on biotech QbD mock submission (CRADA & PQLI)