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The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents related to its requirement for shared risk evaluation and mitigation strategies (REMS) and the process for requesting a waiver of this requirement.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