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K&L Gates Triage: FDA & Health Care Update: The Use of Real-World Data and Real-World Evidence in Medical Product Development

15 December 2017
Presenters: Erica M. Jackson

In this episode, Erica Jackson discusses recent guidance from the Food & Drug Administration (FDA) on the consideration of real-world data and real-world evidence in regulatory decision-making related to medical devices and their development. The episode notes stakeholders should work closely with the FDA so that real-world data collected and maintained during the development process is high quality, relevant, reliable, and stored with the appropriate privacy and data security protections.

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.

Subscribe to Triage via your favorite podcast app to have our episodes delivered directly to you as they become available.

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