About FDA

Study Endpoints and Labeling Development (SEALD) Staff

The Study Endpoints and Labeling Development (SEALD) Staff, located in the Immediate Office in the Office of New Drugs (OND), includes two teams: The Study Endpoints Team and the Labeling Team.  

Our Mission

The Study Endpoints and Labeling Development (SEALD) Staff ensures that meaningful medical product information is available to health care providers, caregivers, and patients through: 

  • advancement of innovation and excellence in clinical trial measurement of treatment benefit including the development and implementation of standards for clinical outcome assessments (COAs) used as effectiveness endpoints, and  

  • development and implementation of review policies to provide medical product labeling that is accurate, consistent, and useful.   

Teams

The Study Endpoints Team

Our Mission
The Study Endpoints Team ensures that treatment benefit is measured appropriately in clinical trials through the use of well-defined and reliable Clinical Outcome Assessments (COAs) to measure effectiveness endpoints.

What We Do

  • Lead the development and implementation of good measurement standards in clinical trials

    • FDA guidance and policy development related to COAs as effectiveness endpoints

    • Training of CDER staff on good measurement standards in clinical trials

    • Outreach to and collaboration with industry, instrument developers, patient representatives, academia, and other government agencies, both Federal and international (e.g., NIH, EMA), to advance the science of measurement in clinical trials 

  • Provide consultation and advice to OND review divisions and other FDA Centers on COA development, validation, and interpretation as effectiveness endpoints in clinical trials for IND, NDA, and BLA submissions

  • Manage and lead the CDER COA Qualification Program

    • Provide consultation and advice to instrument developers to guide the development of COAs ultimately intended for use as primary or secondary endpoints in clinical trials

    • Lead multi-disciplinary teams in the review of submissions for CDER COA qualification

    • Lead CDER participation in public-private partnerships to develop COAs 

Resources:  Clinical Outcome Assessment Qualification Program 

The Labeling Team

Our Mission
The Labeling Team ensures that medical product labeling [i.e., prescribing information (PI)] is a useful communication tool for health care providers, based on regulations and guidances, and conveys the essential scientific information needed to prescribe and use medical products safely and effectively. 

What We Do

  • Assist in labeling review

  • Provide oversight of labeling quality

  • Provide labeling review training

  • Develop and maintain labeling review resources

  • Develop and implement labeling policy initiatives 

Resources:  PLR Requirements for Prescribing Information 
 

Contact Us

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