About FDA

Study Endpoints and Labeling Development (SEALD): Study Endpoints Team

The 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).   

Our Mission 

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
     

Resources:  

 

ContactUs

Mailing Address:
Food and Drug Administration
Center for Drug Evaluation and Research
Office of New Drugs, SEALD, Study Endpoints Team
10903 New Hampshire Avenue, Building 22
Silver Spring, MD 20993
Phone: 301-796-0900 

 

For information about the SEALD Labeling Team and the prescribing information, go to the SEALD Labeling Team  internet site.

Page Last Updated: 04/20/2015
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