Therapeutic Biologics Applications (BLA)

 1999-2003 BLA information is available in the FDA Archive

• Prescription Drug User Fee Act (PDUFA) Billable Products (PDF)  
• Frequently Asked Questions About Therapeutic Biological Products

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

• Investigational New Drug (IND) Application
• New Drug Application (NDA)
• Abbreviated New Drug Application (ANDA): Generics
• Purple Book Database