Regulatory Filing & Pre- License/Pre-Approval Inspections of ...
Regulatory Filing & Pre- License/Pre-Approval Inspections of ...
Regulatory Filing & Pre- License/Pre-Approval Inspections of ...
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Therapeutic Biological ProductsTransferred to CDER in 2003‣ Monoclonal antibodies for in vivo use‣ Proteins intended for therapeutic use that are extractedfrom plants, animals or microorganisms, includingrecombinant versions <strong>of</strong> these products (except clottingfactors)• Cytokines, growth factors, enzymes, immunomodulators, andthrombolytics‣ Growth factors, cytokines, and monoclonal antibodiesintended to mobilize, stimulate, decrease or otherwise alterthe production <strong>of</strong> hematopoietic cells in vivo‣ Most that are regulated by CDER are “specified” biologics8
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