Regulatory Considerations for Cancer Drug Products Containing Nanomaterials

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.