Vaccines, Blood & Biologics
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)
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