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BLA CMA Submission Requirements

Blood Products – CMC Requirements

Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products

Vaccines – CMC Requirements

rDNA and Monoclonal Antibody – CMC Requirements

GUIDANCE FOR INDUSTRY ; FOR THE SUBMISSION OF CHEMISTRY, MANUFACTURING, AND CONTROLS INFORMATION FOR A THERAPEUTIC RECOMBINANT DNA-DERIVED PRODUCT OR A MONOCLONAL ANTIBODY PRODUCT FOR IN VIVO USE

Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use

Analytical: CMC Requirements

Container Closure System – CMC Requirements

Cellular & Gene Therapy Guidance Documents – CMC Requirements

Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)

GUIDANCE FOR THE SUBMISSION OF CHEMISTRY, MANUFACTURING, AND CONTROLS INFORMATION AND ESTABLISHMENT DESCRIPTION FOR AUTOLOGOUS SOMATIC CELL THERAPY PRODUCTS