USA – FDA finalizes guidance for drugs and biologics containing nanomaterials

The US Food and Drug Administration (FDA) has released its final guidance for industry on human drug and biological products that contain nanomaterials.

Initial draft guidance for industry, released in December 2017, noted that FDA doesn’t distinguish between whether a drug or biologic with nanomaterials are benign or harmful, but products containing nanomaterials “may merit particular examination” regarding intrinsic and extrinsic factors to assess risks and benefits. (RELATED: Nanomaterials: FDA Issues Draft Guidance for Drugs and BiologicsRegulatory Focus 18 December 2017)

“FDA believes that a suitable framework for evaluating potential risk(s) associated with drug products containing nanomaterials should assure (1) adequate characterization of the nanomaterial, and (2) adequate understanding of a nanomaterial’s intended use and application, and of how the nanomaterial attributes relate to product quality, safety, and efficacy,” the agency wrote…