Immunotherapy: Open Access
Open Access

Regulatory and FDI Guidelines for Immunotherapeutics

Immunotherapeutic products are target specific and intended for minimal side effects so certain rules must be followed by manufacturer given by FDA under FD&C act and its amendements. FDA ( Food and Drug Administration) regulatory body regulates production and post-production activities of products in conjugation with CBER (Centre for Biologics Evaluation and Research), CDER ( Centre for Drug Evaluation and Research), OBP (Office of Biotechnology Products) and OHOP (Office of Hematology and Oncology Products).

They evaluate for purity, potency, viability, quality of raw materials and reagents used in the manufacture. CBER/OCTGT handles cancer vaccines and cell based immunotherapeutic products. CDER reviews monoclonal antibodies.

Related Journals of Regulatory and FDI Guidelines for Immunotherapeutics

Immunotherapy: Open Access, Immunooncology journal, Immunobiology journal, Immunology Journal, Immunome Research journal, The Journal of Allergy and Clinical Immunology, World Allergy Organization Journal, The Lancet, HHS Public Access, Clinical and Translational Allergy.