Vaccines, Blood & Biologics

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Vaccines, Blood & Biologics
Guidance, Compliance & Regulatory Information (Biologics)
Biologics Procedures (SOPPs)

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About the Center for Biologics Evaluation and Research

Biologics Procedures (SOPPs)

These Standard Operating Procedures and Policies (SOPPs) are used by staff in FDA's Center for Biologics Research and Review (CBER) in the performance of their duties. They are made available here to the public because CBER is committed to being as transparent as possible in how it operates. These SOPPs are organized by area of activity.

Standard Operating Policies & Procedures (SOPPs)

Section 8000: General Information
Section 8100: Communication
Section 8200: Investigational New Drugs (INDs)
Section 8400: License Applications
Section 8500: Compliance
Section 8700: Medical Devices
Section 9150: Office of Cellular, Tissue and Gene Therapies
Section 9200: Vaccines

Recalls & Alerts

Recalls (Biologics)
Biologic Product Shortages
Report a Problem to the Center for Biologics Evaluation & Research

Approvals & Clearances

Biologics Products & Establishments

Contact Us

Consumer Affairs Branch (CBER)
(800) 835-4709
(301) 827-1800
ocod@fda.hhs.gov

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448