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Complexity of Biologics CMC Regulation

  • John Geigert
Chapter

Abstract

The complexity of biologic regulation both within the United States and the European Union is unveiled. As shown in this chapter, the multiple pathways for regulatory approval can appear confusing for biopharmaceuticals and place pressure on the regulatory affairs group within a company, especially in explaining to those in their company why a biologic is treated under one pathway and not another.

Keywords

Biologic Biopharmaceutical Biosimilar CGTP ATMP FD&C Act PHS Act IND NDA BLA IMPD CTA MAA 

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • John Geigert
    • 1
  1. 1.BioPharmaceutical Quality SolutionsCarlsbadUSA

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