Clinical Outcome Assessment Staff Study Endpoints and Labeling Development (SEALD): Study Endpoints Team
The Clinical Outsome Assessments (COA) Staff Study Endpoints and Labeling Development (SEALD) Endpoints Team is located in the Immediate Office in the Office of New Drugs (OND), in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). The COA Staff was previously known as the Study Endpoints and Labeling Development (SEALD) Study Endpoints Team.
To promote the development and implementation of patient-focused endpoint measures in medical product development to describe clinical benefit in labeling
What We Do
Engage with internal and external stakeholders to advance good scientific clinical outcome measurement standards and policy development
Collaborate with the Office of New Drugs review divisions and other FDA Centers by providing consultation and advice on clinical outcome assessment development, validation, and interpretation of clinical benefit endpoints in clinical trials for IND, NDA, and BLA submissions
Address unmet medical needs by managing and leading the CDER Clinical Outcomes Assessment Qualification Program
Food and Drug Administration
Center for Drug Evaluation and Research
Office of New Drugs, SEALD, Study Endpoints Team Clinical Outcome Assessments Staff
10903 New Hampshire Avenue, Building 22
Silver Spring, MD 20993
For information about the Labeling Development SEALD Team and the prescribing information, go to the SEALD Labeling Development Team internet site.