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Vaccines, Blood & Biologics
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Resources for You
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Other Recommendations for Biologics Manufacturers
We have recently redesigned the FDA Web site. As a result, some Web links (URLs) embedded within Guidances, Rules and other documents are no longer valid. If you find a link that does not work, please try searching for the document using the document title. For more assistance, go to Contact FDA.
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Points to Consider
- Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use (PDF - 140KB)
- Draft: Points to Consider in the Design and Implementation of Field Trials for Blood Grouping Reagens and Anti-Human Globulin (PDF - 211KB)
- Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (PDF - 279KB)
- Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology (PDF - 30KB)
- Draft of Points to Consider in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Antibodies to the Human Immunodeficiency Virus, Type 1 (PDF - 1784KB)
- Points to Consider in the Collection, Processing, and Testing of Ex-Vivo Activated Mononuclear Leukocytes for Administration to Humans (PDF - 208KB)
- Supplement to the Points to Consider in the Production and Testing of New Drugs and Biologic & Produced by Recombinant DNA Technology: Nucleic Acid Characterization and Genetic Stability (PDF - 107KB)
- Interferon Test Procedures: Points to Consider in the Production and Testing of Interferon Intended for Investigational Use in Humans (PDF - 545KB)
- Points to Consider in the Manufacture and Testing of Therapeutic Products for Human Use Derived from Transgenic Animals (PDF - 182KB)
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Additional Recommendations
- Draft: Recommended Methods for Evaluating Potency, Specificity, and Reactivity of Anti-Human Globulin (PDF - 1161KB)
- Draft Reviewers' Guide: Disease Associated Antibody Collection Program (PDF - 154KB)
- Draft: Recommended Methods for Blood Grouping Reagents Evaluation (PDF - 2101KB)
- CBER Computer Assisted License Application (CALA) Questionnaire (PDF - 10KB)
- References for the Regulatory Process for the Office of Cellular, Tissue and Gene Therapies
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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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