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.