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Correspondence

• November 5, 2018 Ltr. to Mfr - Option to Lower Lot Release Specification for Required Measles Antibody Potency Testing

Points to Consider

• Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use
• Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals
• Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology
• Points to Consider in the Collection, Processing, and Testing of Ex-Vivo Activated Mononuclear Leukocytes for Administration to Humans
• 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
• Interferon Test Procedures: Points to Consider in the Production and Testing of Interferon Intended for Investigational Use in Humans
• Points to Consider in the Manufacture and Testing of Therapeutic Products for Human Use Derived from Transgenic Animals

Additional Recommendations

• Draft Reviewers' Guide: Disease Associated Antibody Collection Program
• CBER Computer Assisted License Application (CALA) Questionnaire
• References for the Regulatory Process for the Office of Tissues and Advanced Therapies