1. Home
  2. News & Events
  3. News
  4. FDA’s webinar on the COA compendium

FDA’s webinar on the COA compendium

The FDA is organized a live webinar on March 8, 2016; 1:00 PM ET, titled: “Pilot Clinical Outcome Assessment Compendium (COA Compendium).”
This one hour webinar will:

  • Familiarize the audience with the recently announced pilot COA Compendium.
  • Address questions from the audience.

Webinar Info: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm486011.htm
 About the COA Compendium: The pilot COA Compendium organizes and summarizes clinical outcome assessment (COA) information for many different diseases and conditions into a single resource and was recently published for public comment. FDA hopes the COA Compendium will ultimately foster patient-focused outcome measurement by facilitating communication with external stakeholders and providing clarity and transparency to drug developers and the research community. The COA Compendium is intended to be used as a starting point when considering how COAs might be utilized in clinical trials and will likely be most informative early in drug development.
Please visit the following COA Compendium website for more information: www.FDA.gov/COACompendium
The FDA invites stakeholders to submit comments to the Docket No. FDA-2015-N-5106. The docket will close on March 14, 2016. FDA will consider all comments submitted but will generally not respond directly to the person or organization submitting the comment.