U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process (Drugs)
  4. How Drugs are Developed and Approved
  5. Types of Applications
  6. Therapeutic Biologics Applications (BLA)
  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

 

Resources For You