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U.S. Department of Health and Human Services

Combination Products

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Address Update

Office of Combination Products 

Food and Drug Administration 

WO32, Hub/Mail Room #5129

10903 New Hampshire Avenue 

Silver Spring, MD 20993-0002 

Telephone: (301) 796-8930 

fax: (301) 847-8619 

email: combination@fda.gov 

Refer to 21 CFR 3.6 - Product Jurisdiction Officer 


Center for Biologics Evaluation and Research (CBER) Center Contact: 

Sheryl Lard Whiteford, Ph.D. 

Email: sherry.lard@fda.hhs.gov  

Telephone: 240-402-7912  


Center for Devices and Radiological Health (CDRH) Center Contact: 

James Bertram, PhD.

E-mail: CDRHProductJurisdiction@fda.hhs.gov

Telephone: 301-796-9588


Center for Drug Evaluation and Research (CDER) Center Contact: 

Kristina Lauritsen, PhD. and Cherryn Chang, PharmD.

Email: CDERProductJurisdiction@fda.hhs.gov 

Telephone: 301-796-8936