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Regulatory Considerations for Cancer Drug Products Containing Nanomaterials

  • Mamta Kapoor
  • Kathryn Hughes
  • Katherine M. TynerEmail author
Chapter
Part of the Bioanalysis book series (BIOANALYSIS, volume 5)

Abstract

Applications for new pharmaceuticals in the USA are reviewed by the FDA’s Center for Drug Evaluation and Research (FDA/CDER), which evaluates the safety and efficacy of both drug substances and drug products. The degree of innovation and variety in the drug products containing nanomaterials is broad, and the FDA has conceptual and analytical frameworks to capture consistently the risks introduced by new therapeutic approaches. When reviewing drug product applications the Agency considers the entire product, from the data demonstrating clinical efficacy to the chemistry, production, storage, and delivery method(s). These last four areas are collectively evaluated as the quality attributes of a drug, and FDA determined that these have particular importance for drug products containing nanomaterials. The relevant quality attributes are discussed in detail in this chapter following a brief overview of nanomaterials within products designed to treat cancer and a description of the regulatory structure in which applications for cancer therapeutics are reviewed.

Keywords

Nanomaterials United States Food and Drug Administration Center for Drug Evaluation and Research Drug product quality Drug products Active pharmaceutical ingredient Liposome Nanocrystals Critical quality attributes IND NDA ANDA Nanotechnology in cancer therapeutics Doxil® DaunoXome® Generic drugs 505b(1) 505b(2) 505(j) BLA Fast track designation Breakthrough therapy designation Accelerated approval Priority review designation Drug products containing nanomaterials Drug substance 

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Copyright information

© This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply 2019

Authors and Affiliations

  • Mamta Kapoor
    • 1
  • Kathryn Hughes
    • 1
  • Katherine M. Tyner
    • 1
    Email author
  1. 1.Center for Drug Evaluation and Research, US Food and Drug AdministrationSilver SpringUSA

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