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