FDA Draft REMS Guidance: Implications and Opportunities for REMS Lifecycle Management
Wednesday, December 9th, 2009
FDA issued draft Risk Evaluation and Mitigation Strategy (REMS) guidance on September 30th. This guidance comes two years after the introduction of REMS and brings some important direction to the industry about FDA’s latest thinking and expectations. While much within the guidance was anticipated, some aspects, while unexpected, represent exciting opportunities for our industry. These include new options like implementing voluntary risk mitigation measures beyond a REMS, modifying the assessment timetable, and modifying the REMS program and/or its goals.
In this webinar, Dr. Gary Slatko - Chief Medical Officer of ParagonRx, provided an overview of the draft guidance in the context of FDA's previous and current risk management initiatives. In addition, he addressed some aspects of the guidance that, while unexpected, represent exciting opportunities for our industry. The presentation was followed by a question and answer session.
Webinar Slide Set
click to view:
Session Replay
For more information on the guidance, read the recent series of articles on our blog.
Read the related white paper: FDA Draft REMS Guidance - Implications and Opportunities for REMS Lifecycle Management