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  1. How Drugs are Developed and Approved

Therapeutic Biologics Applications (BLA)

Therapeutic Biologics Applications (BLA)

 1999-2003 BLA information is available in the FDA Archive

The therapeutic biological products include:

  • Monoclonal antibodies for in-vivo use
  • Cytokines, growth factors, enzymes, immunomodulators; and thrombolytics
  • Proteins intended for therapeutic use that are extracted from animals or microorganisms, including recombinant versions of these products (except clotting factors)
  • Other non-vaccine therapeutic immunotherapies


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