Guidance, Compliance & Regulatory Information (Biologics)
Guidance documents describe FDA’s interpretation of our policy on a regulatory issue (21 CFR 10.115(b)). These documents usually discuss more specific products or issues that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products. Guidance documents may also relate to the processing, content, and evaluation or approval of submissions as well as to inspection and enforcement policies. Guidance documents are not regulations and alternative approaches may be chosen to comply with laws and regulations.
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Rules, Guidances & Recommendations
Biologics Rules Other Recommendations for Biologics Manufacturers General Biologics Guidances Allergenics Guidances Blood Guidances Cellular & Gene Therapy Guidances Tissue Guidances Vaccine and Related Biological Product Guidances Xenotransplantation Guidances Advisory Committee Guidance Documents Clinical Trials Guidance Documents Combination Products Guidance Documents Guidances (Drugs) Import and Export Guidance Documents International Conference on Harmonisation - Efficacy International Conference on Harmonisation - Joint Safety/Efficacy (Multidisciplinary) International Conference on Harmonisation - Quality International Conference on Harmonisation - Safety