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

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

Date: December 5, 2019 Time: 8:30 AM - 12:00 PM EST Location: FDA White Oak Campus: The Great Room Conference Center 10903 New Hampshire Ave Building 31, Room 1503 Silver Spring, MD 20993 United States

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The U.S Food and Drug Administration (FDA) is hosting a public meeting to provide an opportunity for grantees funded 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.