Guidance, Compliance & Regulatory Information (Biologics)
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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.
Recently Issued Guidance Documents
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 Products Guidances
- Xenotransplantation Guidances
- Advisory Committee Guidance Documents
- Clinical Trials Guidance Documents
- Combination Products Guidance Documents
- Guidances (Drugs)
- Import and Export Guidance Documents
- International Council for Harmonisation - Quality
Compliance & Enforcement
- Compliance Actions (Biologics)
- Enforcement Actions (CBER)
- Exporting CBER-Regulated Products
- Importing CBER-Regulated Products into the United States
- Product Surveillance (CBER)
- Letters to Industry / Healthcare Providers / Clinical Investigators - ARCHIVED
Post-Market Activities
- Lot Release
- Influenza Virus Vaccine Composition and Lot Release
- Postmarketing Clinical Trials
- Postmarketing Reports
Forms
Related Information
- Blood Establishment Registration and Product Listing
- Tissue Establishment Registration
- Regulatory Actions Issued by CBER
- Regulation of the Blood Supply
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Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
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