Wednesday FoREMS: Our “Guidance” on the New FDA Draft Guidance for MedGuides in REMS
Wednesday March 9, 2011
Our “Guidance” on the New FDA Draft Guidance for MedGuides in REMS
On February 28, FDA issued Draft Guidance for Industry: Medication Guides – Distribution Requirements and Inclusion in REMS. In addition to other topics, this guidance addresses how a Medication Guide will be required as part of a REMS. Given that 67% of all REMS programs include only MedGuides and Assessments as program elements, the implications of this draft guidance are essential knowledge for industry professionals.
Topics:
- Review provisions of Draft Guidance
- Implications and commentary
- Recommendations
In this webinar we will review the newly issued FDA draft guidance for MedGuides in REMS, explore implications for you and your product, and discuss the new, unexpected, and interesting insights.
Presenters:
- Jeff Fetterman, President – ParagonRx
- William (Billy) Holden, PhD -- Chief Safety Officer – ParagonRx
- Karen Lenoir, Client Services Director – ParagonRx
Webinar Slide Set:
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Session Replay:
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