Office of New Drug’s Labeling Team
Office of New Drug’s Labeling Team is located in the Office of New Drugs in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA).
Our Mission
The Labeling Team helps to ensure that the Prescribing Information (PI):
- Is a useful communication tool for health care practitioners
- Meets statutory requirements
- Is consistent across CDER-regulated prescription drugs, as appropriate
- Contains a summary of the essential information for the safe and effective use of the drug
Responsibilities Include:*
- Assists in labeling review [through Associate Directors for Labeling (ADLs)]
- Serves as OND’s point of contact for novel or complex labeling issues
- 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
* Under this heading, labeling refers to the PI for human prescription drug and biological products
Contact Us
Mailing Address:
Food and Drug Administration
Center for Drug Evaluation and Research
Office of New Drugs, Office of New Drug Policy, Labeling Policy 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.