Overview

The FDA recently released two draft guidance documents, “Development of a Shared System REMS” and “Waivers of the Single, Shared System REMS Requirement.”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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$99
  • +$100 for nonmembers

Speakers

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

On-demand webinar recordings are sent via email as soon as we are able to process and verify your order. This usually occurs within 1 business day of your purchase.

On-demand content can be played back on most devices.

If you have concerns, please click the Test Your System link to determine your device’s compatibility, as well as system requirements.