Single, Shared System Risk Evaluation and Mitigation Strategies: Opportunities and Challenges

Lynn Mehler was a speaker during a Food and Drug Law Institute (FDLI) live webinar on 14 May.

The speakers discussed the U.S. Food and Drug Administration's (FDA) draft guidance documents, "Development of a Shared System REMS" and "Waivers of the Single, Shared System REMS Requirement" and how these affect the medical products community as well as public health.

Learn More: Single, Shared System Risk Evaluation and Mitigation Strategies: Opportunities and Challenges


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