Characterizing FDA’s Approach to Benefit-Risk Assessment throughout the Medical Product Life Cycle

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May 16, 2019
Tommy Douglas Conference Center
Silver Spring, MD
United States

The US Food & Drug Administration (FDA) and the Duke-Margolis Center for Health Policy will be hosting a public meeting on how benefit-risk assessment factors into regulatory decisions in drug development. 

The meeting will cover:

  • FDA’s planned benefit-risk assessment guidance
  • Activities that occur in pre-market development that best inform FDA’s benefit-risk assessment
  • Effective communication of benefit-risk assessment information
  • Use of benefit-risk assessment to inform FDA and sponsor decision-making in the post-marketing setting.

Brett Hauber, Senior Economist and Vice President of Health Preference Assessment at RTI Health Solutions, will participate as a panelist in the session,  Activities that Occur in Pre-Market Development that Best Inform FDA’s Benefit-Risk Assessment. 

Learn more about the meeting and access additional resources, click here.

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