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Regulatory strategy and approval processes considered for PEG-drug conjugates and other nanomedicines

  • Viegas T
  • Veronese F
Birkhäuser Basel, (2009), 273-281
DOI: 10.1007/978-3-7643-8679-5_16
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Abstract

Therapeutic products prepared by PEG conjugation currently undergo the same regulatory scrutiny as small molecule drugs. A brief review of historical and current regulatory submission strategies is discussed in this chapter. In addition, some forward looking suggestions and considerations are made for nanomedicines that employ PEG and other polymers.

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Viegas, T. X., & Veronese, F. M. (2009). Regulatory strategy and approval processes considered for PEG-drug conjugates and other nanomedicines. In PEGylated Protein Drugs: Basic Science and Clinical Applications (pp. 273–281). Birkhäuser Basel. https://doi.org/10.1007/978-3-7643-8679-5_16

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