On September 30th, FDA issued draft guidance, “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments and Proposed REMS Modifications”. While much of this draft guidance is a codification of what’s already been happening in practice over the past 2 years, there are a few interesting surprises (depicted in bold below) for those working in the REMS space to contemplate. This is the fourth in an ongoing series of blog articles about this important document.
Our first three articles covered the background of FDAAA and REMS, an overview of a REMS submission and greater detail about the “Proposed REMS”, and “REMS Supporting Document” components of the REMS document submission. This article covers the section of the guidance about “REMS assessment and modification submissions” and “communicating with FDA”. (more…)
