K&L Gates Triage: REMS…Sharing Is So Hard to Do

The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents related to its requirement for shared risk evaluation and mitigation strategies (REMS) and the process for requesting a waiver of this requirement. In this episode, Michael Hinckle summarizes current requirements for single shared system (SSS) REMS and explains how the new guidance documents may assist generic drug applicants negotiating SSS issues with brand competitors.

About Triage
Triage: Rapid Legal Lessons for Busy Health Care Professionals has been created by K&L Gates to convey information about developments in health law through short podcasts.

If you work in the health care industry, you have grown accustomed to frequent changes in laws and regulations. On some days, it may seem like an insurmountable task to keep up with every change, especially as a new presidential administration and new policies take shape.

The K&L Gates Health Care Practice will regularly create Triage podcasts to help you learn about the latest developments in health law. Our lawyers will identify the most important changes and analyze the impact of these changes on our clients.

Catch-up on past episodes by visiting our Triage program page.

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