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Triage: Rapid Legal Lessons for Busy Health Care Professionals is a podcast created by the K&L Gates health care practice group to inform our clients and friends of the firm about the latest developments in health law. If you would like to provide feedback or would like to suggest a topic for a future episode of Triage, please contact us. Use the icons below to subscribe to Triage via your favorite podcast app to have our episodes delivered directly to you as they become available.

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  2. K&L Gates Triage: REMS…Sharing is so hard to do

K&L Gates Triage: REMS…Sharing is so hard to do

Aug 9, 2018

The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents related to its requirement for shared risk evaluation and mitigation strategies (REMS) and the process for requesting a waiver of this requirement.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.

Presenters: Michael H. Hinckle

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