Guidance, Compliance & Regulatory Information (Biologics)

Search all FDA Guidance Documents

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

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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 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 (ICH) Guidances

1. Click the following link to go to the Search for FDA Guidance Documents page
2. Scroll down to the FDA Organization Guidance Document Search Filter and select Center for Drug Evaluation and Research from the dropdown list
3. Use the Topic Filter option to select one of the following ICH guidance document topic filter options:

• ICH-Efficacy

• ICH-Multidisciplinary

• ICH-Quality

• ICH-Safety

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
• Seasonal Information for Influenza Virus Vaccine
• Postmarketing Clinical Trials
• Postmarketing Reports

Forms

• Forms
• Requesting Forms from the Warehouse

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Related Information

• Blood Establishment Registration and Product Listing
• Tissue Establishment Registration
• Regulatory Actions Issued by CBER
• Regulation of the Blood Supply

 

Follow CBER

Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002

ocod@fda.hhs.gov

(800) 835-4709
(240) 402-8010

For Updates on Twitter, follow @fdacber

• Resources for You (Biologics)
• About the Center for Biologics Evaluation and Research (CBER)
• Report a Problem to the Center for Biologics Evaluation & Research
• Recalls (Biologics)
• CBER-Regulated Products: Shortages and Discontinuations
• Biologics Products & Establishments