December 9, 2010
FDA Draft REMS Guidance: Implications and Opportunities for REMS Lifecycle Management This one-hour webinar features an overview of the recent FDA draft REMS guidance in the context of FDA's previous and current risk management initiatives, a discussion of the aforementioned topics of interest, and a question and answer session.
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.
This one-hour webinar features an overview of the draft guidance in the context of FDA's previous and current risk management initiatives by Dr. Gary Slatko - Chief Medical Officer of ParagonRx, a discussion of the aforementioned topics of interest, and a question and answer session.For more information on the guidance, read the recent series of articles on our blog.
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