About FDA

Labeling Development Team


The Labeling Development Team (LDT) is located in Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA).

Our Mission 

The LDT develops prescription drug labeling regulations, FDA guidance, and CDER policies, and oversees their implementation to help ensure that the Prescribing Information (PI):
  • Is a useful communication tool for health care practitioners
  • Meets statutory/regulatory requirements and is appropriately consistent with guidance recommendations and CDER policies
  • Is appropriately consistent across CDER-regulated prescription drug and biological products  
Responsibilities Include:*
  • Assists in labeling review [through Associate Directors for Labeling (ADLs)]
  • Serves as OND’s point of contact for labeling issues with policy implications
  • Oversees labeling practices to improve labeling quality
  • Provides labeling review training
  • Mentors OND ADLs and leads ADL workshops
  • Develops and maintains labeling review resources for CDER and stakeholders
  • Leads labeling outreach to stakeholders
  • Participates in and leads labeling policy initiatives

* Under this heading, labeling refers to the PI for human prescription drug and biological products

Resources

PLR Requirements for Prescribing Information Website


Contact Us

Mailing Address:
Food and Drug Administration
Center for Drug Evaluation and Research
Office of New Drugs, Labeling Development Team
10903 New Hampshire Avenue, Building 22
Silver Spring, MD 20993
Phone: 240-402-4768 (for general questions about the prescribing information)
For questions about FDA-approved patient labeling or carton/container labeling, please contact druginfo@fda.hhs.gov, 1-855-543-3784, or 1-301-796-3400. 
 

Page Last Updated: 09/27/2018
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