Public Meeting on CDER Standard Core Sets Clinical Outcome Assessments and Endpoints Grant Program - Drug Information Update

Public Meeting on CDER Standard Core Sets Clinical Outcome Assessments and Endpoints Grant Program

On August 28, 2020, the U.S. Food and Drug Administration will host, via a live virtual webcast, a Public Meeting on CDER Standard Core Sets Clinical Outcome Assessments and Endpoints Grant Program to provide an opportunity for grantees funded in 2019, as part of the FDA Standard Core Clinical Outcome Assessments (COAs) and Endpoints Pilot Grant Program, to share their development plans for the standard core COA sets and to receive feedback from stakeholders. FDA will provide an introduction and discuss plans for the pilot grant program including future public meetings. As part of our Patient Focused Drug Development (PFDD) efforts, the FDA developed a pilot grant program to support the development of publicly available standard core set(s) of COAs and their related endpoints for specific disease indications. On September 11, 2019 the FDA made three awards under this grant program in the areas of: (1) migraine, (2) acute pain in infants and young children, and (3) physical function across a range of chronic conditions. The purpose of this public meeting is to ensure that, as these standard core sets of clinical outcome assessments are developed, the identified concepts, COAs, and endpoints reflect what is most important and relevant to patients and support regulatory and potentially other stakeholder decision making. Persons interested in attending this public meeting must register online for the webcast.