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PDUFA V Clinical Outcome Assessments: Public Workshop

The Food and Drug Administration (FDA) is announcing a public workshop entitled: Clinical Outcomes Assessment Development and Implementation: Opportunities and Challenges. The purpose of the public workshop is to provide updates on accomplishments, challenges, and ongoing efforts in the use of clinical outcome assessments (COAs), and plan for the future of COA development and utilization in drug development programs, including how to incorporate the patient voice in drug development using well-defined and reliable patient-centered outcome measures. The public workshop will also discuss standards for COA use and collaborative processes for COA development and dissemination.

The public workshop will be held on:


April 1, 2015


8:30 a.m. to 5:00 p.m.


The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public workshop participants (non-FDA employees) is through Bldg. 1 where routine security check procedures will be performed. For parking and security information, please refer to Public Meetings at the FDA White Oak Campus


Participation can be either in person attendance or by webcast. There is no fee to attend the public workshop, but attendees should register in advance. Space is limited, and registration for in person attendance will be on a first-come, first-served basis.

Before March 27, 2015, we ask all persons who wish to participate either in person or by webcast to Register onlinedisclaimer icon.

For those without Internet access, please contact Michelle Campbell at 240-402-6019.

Webcast Information

Access the webcast at: Clinical Outcomes Assessment Public Workshop. This link will be active on the day of the meeting.

Additional Questions

If you have additional questions, please contact




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