The Food and Drug Administration (FDA) is seeking public comments regarding its draft guidance documents for applicants with drug products that contain nanomaterials. While nanomaterials are conventionally referred to as materials with at least one dimension between 1 and 100 nanometers, the FDA expands its consideration to include materials designed to exhibit dimension-based properties with sizes up to 1 micrometer. The FDA acknowledges that it evaluates nanomaterial-containing drug products on a case-by-case basis and uses a risk-based approach. In its reviews, the FDA considers the physicochemical properties of nanomaterials, such as surface charge and agglomeration, but it also emphasizes that applicants should provide structural information like crystal form when applicable. Lastly, the FDA clarifies how applicants should approach nanomaterial analyses and integrate their findings throughout manufacturing processes and product development.
In particular, the FDA is looking for feedback in regard to its terminology. More information is available at the Federal Register.