Public Meeting on the Center for Drug Evaluation and Research Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program-Summer 2020; Public Meeting; Request for Comments

Resumo

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following virtual public meeting entitled "Public Meeting on CDER Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program--Summer 2020." The purpose of the public meeting is to 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, as well as other government and academic researchers, health care providers, health technology assessors and health payers are encouraged to attend the meeting.