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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Biologics Rules

Proposed & Final Rules specifically related to biologics are organized by biologics product area.  Cross-Center and Office of the Commissioner Proposed and Final Rules are posted in a general FDA Rules section.

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
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002
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