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Updated Version of Clinical Outcome Assessment Compendium -USFDA

The COA Compendium is part of the FDA’s efforts to foster patient-focused drug development. The COA Compendium is intended to facilitate communication and to provide clarity and transparency to drug developers and researchers by collating and summarizing clinical outcome assessment (COA) information for many different diseases and conditions into a single resource.

The U.S Food and Drug Administration (FDA) recently released the updated version of the Clinical Outcome Assessment Compendium (COA Compendium) to encourage the development and implementation of patient-focused clinical outcome assessments (COAs) in clinical trials to support drug approvals and labeling claims.

  1. The updated COA Compendium is an extension of the previously updated document published in 2019 and includes additional COAs from the following major sources:

    1. NME and BLA labels from July 2017 to June 2019, efficacy supplements pertaining to new indications and new populations from July 2017 to June 2018.

    2. Qualified measures based on CDER's COA DDT qualification program.

  2. The drug’s name and approval date corresponding to the labeling from which the COA was extracted is included in the updated Compendium document.

  3. The COA Compendium update does not refer to COAs in development or under review within FDA’s DDT Qualification program, because these instruments have not received full FDA review and qualification for the proposed use and may not yet be publicly available.

For more information visit the COA Compendium website.


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