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U.S. Department of Health and Human Services

Safety

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Contact Information for Questions About MANDATORY Reporting

 

 

Drugs

For Investigational New Drugs (INDs):

For questions on specific INDs, contact the assigned regulatory project manager - his or her name is on the acknowlegement letter and other correspondence from FDA about the IND.

For general questions on INDs, contact:

Office of New Drugs, Immediate Office, Regulatory Affairs Team
Building 22, Mail Stop 6411
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
301-796-0700
e-mail: ondeio@fda.hhs.gov

For Marketed Drugs:

Office of Surveillance and Epidemiology
Building 22, Mail Stop 3411
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
(301) 796-2380
 

Biologics, Including Vaccines; Blood Components and Derivatives; Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Allergenic Extracts; Therapeutic Vaccines (e.g., BCG), Diagnostic Biologics (e.g., PPD)

Division of Epidemiology (HFM-220)
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
Phone: (301) 827-3974
Fax: (301) 827-5218

Devices

U.S. Food and Drug Administration
Center for Devices and Radiological Health
OSB/Reporting Systems Monitoring Branch
WO Bldg. 66 Rm. 3217
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002 

Interpretation of policy: (301) 796-6670 (voice)
Emergencies outside of normal East Coast business hours: 1-866-300-4374 or 301-796-8240 (voice - 24 hours/day)