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Vaccines, Blood & Biologics
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Resources for You
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Biologics Products & Establishments
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Product Approvals & Clearances with Supporting Documents
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Product / Manufacturer Lists
- 510(k) Blood Establishment Computer Software
- Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
- Testing HCT/P Donors for Relevant Communicable Disease Agents and Diseases
- Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P) List of Registered Establishments
- Immune Globulin Intravenous (IGIV) Indications
- Complete List of Licensed Products and Establishments
- Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 862KB)
- Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 37KB)
- Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 165KB)
- Complete List of Vaccines Licensed for Immunization and Distribution in the US
- Devices Regulated by the Center for Biologics Evaluation and Research
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Reports
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Related Resources
- Compliance Actions (Biologics)
- Risk Evaluation and Mitigation Strategies 3/27/08 Federal Register Notice
Identification of Drug and Biological Products Deemed to Have Risk Evaluation and Mitigation Strategies for Purposes of the Food and Drug Administration Amendments Act of 2007 - National Drug Code Directory
Search commercially distributed prescription drugs and insulin products - Pregnancy & Lactation Labeling
- Transfer of Therapeutic Products to the Center for Drug Evaluation and Research
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Contact Us
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Consumer Affairs Branch (CBER)
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
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