If your company has nanomaterials in any drug (including OTC drugs) or biologic products sold in the US, this Guidance is important to you. The US Food and Drug Administration (FDA) has recently released its final industry guidance on human drug and biological products containing nanomaterials. This guidance is for applicants and sponsors of investigational, premarket and post market submissions of products. While there is no regulatory definition of nanomaterial, the FDA considers it products or materials with at least one external dimension or internal or surface structure in the nanoscale range, approximately 1 nm to 100 nm.

This guidance is comparable to one which was published in 2014 concerning cosmetic products. For the sale of cosmetic products containing nanomaterial ingredients, the FDA published recommendations for safety assessments for cosmetics to address certain important factors including characterizations of the nanomaterial ingredient, the safety assessment of nanomaterials and considerations for its toxicology when developing cosmetic products containing nanomaterials.

This guidance, which was initially drafted in 2017 will be concerning the development of OTC drug products in which a nanomaterial is present in the finished dosage form. It should be noted that this guidance should be viewed as recommendations for monograph drug manufacturers unless specific regulatory requirements are cited.

The guidance highlights the need to obtain further understanding of the interactions of nanomaterials within the body, including both intrinsic and extrinsic factors, as well as how these attributes will impact the overall product quality, safety and efficacy. These considerations presented in this guidance include drug development, safety evaluation and quality considerations

The FDA proposes a risk-based approach when developing nanomaterial-containing drugs, with a focus on the following risk factors:

  • Adequacy of characterization and function of the nanomaterial
  • Complexity of the nanomaterial structure
  • Understanding of the mechanism by which the physiochemical properties of the nanomaterial impact its biological effects
  • Predictability of in vivo release based on in vitro methods
  • Physical and chemical stability
  • Route of administration

The information of the structure of a specific nanomaterial can be referenced within the appropriate letter of authorization as part of the drug application or to a drug master file. This is to ensure adequate characterization of the nanomaterial and understanding of the nanomaterial’s intended use and application. It should be noted that this list is not comprehensive and other risk factors may need to be evaluated during product development.

Moreover, as a guidance document, the information issued are considerations for the industry for drug manufacturers when submitting applications, including Investigational New Drug Applications, New Drug Applications, Biological License Applications, Abbreviated New Drug Applications and Drug Master Files. The FDA suggests that as the drug product development progresses, more information will be obtained about the nanomaterial and understanding will continue to be revised based on findings.

If you need any assistance or have any questions about whether this applies to your company or have any concerns, do not hesitate to contact us.