Drug Nanomaterial Guidance Explained

An FDA guidance, Drug Products, Including Biological Products, that Contain Nanomaterials, focuses on identifying and managing risks that are present when nanomaterials are part of a product, according to CDER Office of Pharmaceutical Quality review chemist Andrei Ponta. Speaking on a CDER Small Business and Industry Assistance Chronicles podcast, Ponta says that while the same standards of safety, efficacy, and quality apply to products containing nanomaterials as to other drug products, nanotechnology is relatively new in the field of medicine and the guidance is intended to help FDA and industry think through any unknowns that may arise.

The document acknowledges that nanomaterials may also be present as inactive ingredients or excipients. It discusses how, for example, the purity of the lipids in a liposome or the molecular weight of polymers in a nanomaterial drug delivery system may be critical.