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.
Should you find a link that does not work within any Guidance document, Rule or other document posted on the FDA Web site, please try searching for the document using the document title. If you need further assistance, please go to Contact FDA.
General Biologics Guidances Allergenics Guidances Blood Guidances Cellular & Gene Therapy Guidances Tissue Guidances Vaccine and Related Biological Product Guidances Xenotransplantation Guidances Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2016(PDF - 41KB)
Jointly issued or Agency-level guidances
Advisory Committee Guidance Documents Clinical Trials Guidance Documents Combination Products Guidance Documents FDA Guidance Documents: General and Cross-Cutting Topics Import and Export Guidance Documents International Council for Harmonisation - Efficacy International Council for Harmonisation - Joint Safety/Efficacy (Multidisciplinary) International Council for Harmonisation-Quality International Council for Harmonisation - Safety Veterinary International Conference on Harmonization (VICH) Guidance Documents