Vaccines, Blood & Biologics
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Biologics Products & Establishments
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Product Approvals & Clearances with Supporting Documents
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Product / Manufacturer Lists
Biological Approvals by Year 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 FDA Online Label Repository Complete List of Licensed Products and Establishments Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 223KB)Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 14KB)Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 41KB)Complete List of Vaccines Licensed for Immunization and Distribution in the US Devices Regulated by the Center for Biologics Evaluation and Research Variances for Collection of Blood and Blood Products from Patients with Hemochromatosis Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
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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 2007National Drug Code Directory
Search commercially distributed prescription drugs and insulin productsTransfer of Therapeutic Products to the Center for Drug Evaluation and Research
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Other Product Approval Information
Drug Approvals and Databases
Center for Devices and Radiological HealthDevice Approvals and Clearances
Center for Devices and Radiological HealthRadiation-Emitting Products and Procedures
Center for Devices and Radiological HealthProducts
Center for Devices and Radiological Health
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Contact FDA
(800) 835-4709
(301) 827-1800
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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