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        Guidance, Compliance & Regulatory Information (Biologics)

Other Recommendations for Biologics Manufacturers Home
          Vaccines, Blood & Biologics
          Guidance, Compliance & Regulatory Information (Biologics)
          Other Recommendations for Biologics ManufacturersGuidance, Compliance & Regulatory Information (Biologics) Other Recommendations for Biologics Manufacturers
  	
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November 5, 2018 Ltr. to Mfr - Option to Lower Lot Release Specification for Required Measles Antibody Potency TestingPoints 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 AnimalsAdditional 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 TherapiesSub-Topic Paragraphs
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                                                                                  Content current as of:
      01/27/2021
                  
                   
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