The FDA recently released two draft guidance documents, “Development of a Shared System REMS” and “Waivers of the Single, Shared System REMS Requirement.” These guidances establish the conditions when a Single, Shared System Risk Evaluation and Mitigation Strategy (SSS REMS) is required or may be beneficial to sponsors, and how to request a waiver from a SSS REMS. While the FDA may require generic drug manufacturers to share an SSS REMS with the listed drug manufacturer in order to manage and mitigate the drug’s potential safety risks, SSS REMS are very difficult, and in some cases impossible, to achieve and can be a potential reason for delayed generic drug entry to the market.

In this 90-minute webinar, experts will discuss the impact of these guidances on both the medical products community and on public health and access. The webinar will also cover issues companies face in developing an SSS REMS, and the impact the CREATES Act, if passed by Congress, would have on addressing REMS concerns.

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Elaine Lippmann, Senior Regulatory Counsel, FDA – CDER
Lynn Mehler, Partner, Hogan Lovells US LLP
Rachel Turow, Executive Counsel – Regulatory Law, TEVA Pharmaceuticals USA, Inc.
Moderated by Frederick Ball, Partner, Duane Morris LLP and Treasurer, FDLI Board of Directors

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