FDA Updates Clinical Outcome Assessment Compendium (COA Compendium) - Drug Information Update

If your email program has trouble displaying this email, view it as a web page. FDA Updates Clinical Outcome Assessment Compendium (COA Compendium) 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. The COA Compendium is a communication tool that organizes and summarizes COA information for many different diseases and conditions into a single resource. FDA hopes this will facilitate communication with industry and researchers and provide 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.  The updated COA Compendium is an extension of the previously updated document published in 2019 and includes additional COAs from the following major sources: 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, and qualified measures based on CDER's COA DDT qualification program. The drug's name and approval date corresponding to the labeling from which the COA was extracted is included in the updated Compendium document. Clinical and COA Staff reviews are available publicly for many of these drugs on the internet in the Drugs@FDA database, if further information is desired. 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. Ongoing qualification projects are listed separately on the public COA Qualification website. This reflects the transparency provision of the 21st Century Cures Act. For more information visit the COA Compendium website. This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov. Stay Connected with U.S. Food and Drug Administration:         SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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