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U.S. Food and Drug Administration

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Office of Combination Products

Overview of the
Office of Combination  Products

Definition of a Combination Product

Product Jurisdiction/Assignment of Combination Products:

Definition of the Primary Mode of Action of a Combination Product       [PDF 63KB] -- Comment Period Extended [PDF 96KB]

Combination Products Primary Mode of Action (PMOA) Proposed Rule:  May 7, 2004, Federal Register - Presentation

Guidance Documents and Procedures

Reports and Workshops

What's New

Contact Us
We are interested in your comments and suggestions about combination products issues. Please contact:

Mark D. Kramer, Director
Office of Combination Products
Food and Drug Administration
15800 Crabbs Branch Way (HFG-3)
Suite 200
Rockville, MD 20855
(301) 427-1934
(301) 427-1935 fax
email: combination@fda.gov

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