FDA'S NEW STRUCTURE
CBER will lose authority for some therapeutics:
• monoclonal antibodies
• cytokines, growth factors, enzymes, interferons
• proteins extracted from animals or microorganisms
• some immunotherapies
CBER will retain authority for:
• processes using monoclonal antibodies, cytokines, growth factors, and proteins for products under CBER's jurisdiction
• viral-vectored gene therapy
• products composed of human or animal cells or their parts
• blood and components, including recombinant versions
• plasma expanders
• allergen patch tests and allergenics
• antitoxins, antivenins, and venoms
• toxoids and toxins intended for immunization
• vaccines
• in vitro diagnostics