Other Recommendations for Biologics Manufacturers
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Correspondence
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
Sub-Topic Paragraphs
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