Vaccines, Blood & Biologics
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Other Recommendations for Biologics Manufacturers
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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 - 1.7MB)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 - 1.1MB)Draft Reviewers' Guide: Disease Associated Antibody Collection Program (PDF - 154KB)Draft: Recommended Methods for Blood Grouping Reagents Evaluation (PDF - 2.1MB)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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