Nanomaterials: FDA Issues Draft Guidance for Drugs and Biologics
Posted 18 December 2017 | By
The US Food and Drug Administration (FDA) on Friday issued draft guidance detailing a risk-based framework for drugs and biologics containing nanomaterials or made using nanotechnology.
According to the agency, nanomaterials can perform a variety of functions in drug products, such as improved targeting of a particular organ or increased bioavailability.
FDA says it does not "categorically judge" drugs and biologics containing nanomaterials to be "intrinsically benign or harmful," but notes that the inclusion of such materials "may merit particular examination.
"Compared to other products, further understanding may be needed regarding the interactions of nanomaterials with biological systems," FDA writes.
As such, FDA says that adequate characterization of a nanomaterial and understanding of its intended use and application provide a suitable framework for evaluating potential benefits and risks.
The agency also says the recommendations made in the new draft guidance are consistent with its 2014 guidance on nanotechnology and other federal guidance on emerging technology and nanotechnology.
While FDA does not strictly define nanotechnology or nanomaterials, it says it will ask sponsors two questions to determine whether a product is made using nanotechnology:
- "Whether a material or end product is engineered to have at least one external dimension, or an internal or surface structure, in the nanoscale range (approximately 1nm to 100nm)"
- "Whether a material or end product is engineered to exhibit properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer (1,000nm)"
When assessing a nanomaterial, FDA says sponsors should consider a number of factors, including the adequacy of their characterization of the material, its structural complexity and the understanding of how the physiochemical properties of the material impact its effects in the body.
The guidance also includes quality and chemistry, manufacturing and controls (CMC) considerations, recommendations for nonclinical and clinical development, and advice on conducting environmental impact assessments for products containing nanomaterials.
Federal Register Notice, Draft Guidance