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  1. Office of Medical Products and Tobacco

Drug Application and Approval Process - "Questions and Answers"

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

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