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U.S. Department of Health and Human Services

About FDA

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Drug Application and Approval Process - "Questions and Answers"

Submit a question using the link provided below, and your question/answer may be added to this list. (Responses will also be sent to you directly.)

Food and Drug Administration
Center for Drug Evaluation and Research
Division of XXXX Products
5901-B Ammendale Road
Beltsville, MD 20705-1266

  1. Monocolonal antibodies for in vivo use
  2. Proteins intended for therapeutic use, including cytokines, enzymes, and other novel proteins
  3. Immunomodulators
  4. Growth factors, cytokines, and monoclonal antibodies intended to mobilize, stimulate, decrease, or otherwise alter the production of hematopoietic cells in vivo
 

Contact FDA

301-796-0700
Fax:301-796-9856
Office of New Drugs

Immediate Office - Mail Stop 6311

10903 New Hampshire Avenue

Silver Spring, MD 20993