December 2018

2017 FDA Guidance: Many In Vitro DDI Evaluations Should Precede FIH Studies

Author: Dr. Brian Ogilvie, Andrea Wolff Posted: 06 December 2018

While the 2017 FDA DDI guidance contains many important changes, the earlier timing of drug-drug interaction studies is perhaps the most daunting. This is especially true for developers with drugs in the later clinical stages. Does this guidance mean sponsors are required to backtrack, and if so, how far? This article outlines the implications of these new timing requirements and best practices for negotiating them efficiently and effectively moving forward...

Read more