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Pharmaceuticals / Regulatory Affairs

FDA Will Hold Public Meeting on Benefit-Risk Assessments

May 1, 2019

The FDA has announced a public meeting and opportunity for public comment on the agency’s approach to benefit-risk assessments for drugs.

The event is scheduled to be held on May 16 at the Tommy Douglas Conference Center in Silver Spring, Maryland.

The agency said it wants to “gather industry, patient, researcher, and other stakeholder input on applying FDA’s Benefit-Risk Framework throughout the human drug lifecycle and best approaches to communicating FDA’s benefit-risk assessment.”

Feedback gathered from meeting participants will contribute to the development of a draft guidance on benefit-risk assessments for biologics and new drugs and will lead to a publicly available summary report.

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