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  1. Guidance, Compliance & Regulatory Information (Biologics)

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: Marketing Applications
Section 8500: Compliance
Section 8700: Medical Devices
Section 9150: Office of Tissues and Advanced Therapies

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Contact Point
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

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

Hours Available

Food and Drug Administration
Food and Drug Administration
White Oak Campus

10903 New Hampshire Ave
Silver Spring, MD 20993
United States

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