GESTIÓN EN SALUD PÚBLICA: CDER SBIA Update: FDA Releases the Pilot Version of the Clinical Outcome Assessment Compendium (COA Compendium) for public comment

miércoles, 13 de enero de 2016

CDER SBIA Update: FDA Releases the Pilot Version of the Clinical Outcome Assessment Compendium (COA Compendium) for public comment

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

FDA Releases the Pilot Version of the Clinical Outcome Assessment Compendium (COA Compendium) for public comment

Today FDA released the pilot 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 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.

FDA is seeking public feedback on the utility of the COA Compendium, the approach for development of the Compendium, and any suggestions for future approaches and expansion of the document. Comments to the docket will be accepted until March 13, 2016.

FDA will also host a webinar to review the compendium and answer any questions and will update stakeholders with details when available. For more information visit the COA Compendium website. You may also submit your questions/inquiries to COACompendium@fda.hhs.gov.

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.