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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Guidance, Compliance & Regulatory Information (Biologics)

Should you find a link that does not work that's embedded within Guidance documents, Rules, and other documents posted on the FDA Web site, please try searching for the document using the document title. For more assistance, go to Contact FDA.

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Approvals & Clearances

 

Contact FDA

(800) 835-4709
(301) 827-1800
Manufacturers Assistance and Technical Training Branch (CBER)

Division of Manufacturers Assistance and Training

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-41

Rockville, MD 20852-1448
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