The CDER Clinical Outcome Assessment (COA) Qualification Program
- Manages the qualification process for COAs intended to address unmet public health needs.
- Works directly with requestors in guiding COA development for qualification.
- Encourages a collaborative, multidisciplinary setting where CDER can review COAs and provide advice on the development or modification of COAs outside the IND/NDA/BLA pathway.
COA qualification is a regulatory conclusion that the COA is a well-defined and reliable assessment of a specified concept of interest for use in adequate and well-controlled (A&WC) studies in a specified context of use. COA qualification represents a conclusion that within the stated context of use, results of assessment can be relied upon to measure a specific concept and have a specific interpretation and application in drug development and regulatory decision-making.
Please be advised that formal regulatory qualification is a multi-year process. Qualification is not required for a COA to be successfully used in clinical trials and drug development to support regulatory decision making.
If you are interested in potentially participating in the qualification program, we highly encourage you to email COADDTQualification@fda.hhs.gov to schedule an information session to learn valuable information related to the qualification process requirements.