FDA to Hold Public Meeting on Patient Perspectives and Structured Risk-Benefit Assessments

August 10, 2017

The FDA scheduled a public meeting for Sept. 18 on the structured assessment of benefits and risks in drug regulatory decision making. The meeting will focus on regulatory and industry experiences and ways to incorporate patient perspectives.

The meeting will include a series of presentations followed by discussions with panelists and audience members. Those wishing to attend must register by Sept. 11.

The meeting fulfills requirements under PDUFA V to hold at least two workshops on the topic, the agency said. The previous workshop was held in 2014. PDUFA’s goals included the development of a more structured approach to assessing risks and benefits in the drug review process.

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