2019 Public Meeting on Center for Drug Evaluation and Research Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program; Public Meeting; Request for Comments

摘要

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled "2019 Public Meeting on CDER Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program." The purpose of the public meeting is to help ensure that as standard core sets of clinical outcome assessments (COAs) are developed as part of the FDA pilot grant program, the identified concepts, COAs, and endpoints reflect what is most important to patients and relevant to regulatory and potentially other stakeholder decision making. To facilitate this, stakeholders including patients, care partners, FDA reviewers, drug developers, other government and academic researchers, health care providers, health technology assessors and health payers are encouraged to attend the meeting.