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If you work in the health care industry, you have grown accustomed to frequent changes in laws and regulations. Triage: Rapid Legal Lessons for Busy Health Care Professionals, created by K&L Gates, provides its listeners with timely content regarding regulatory and legal developments in the health care industry.  

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The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents related to its requirement for shared risk evaluation and mitigation strategies (REMS) and the process for requesting a waiver of this requirement.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