title: Product quality for nanomaterials: current U.S. experience and perspective.
abstract: In recent years, there has been an increased focus on developing novel drug delivery systems and targeted therapies through the use of nanotechnology and nanomaterials. Such focus is translating to an increasing number of investigational new drug (IND) applications, new drug applications (NDAs), and abbreviated new drug applications (ANDAs) for drug products containing nanomaterials to the United States Food and Drug Administration (FDA). Although subject to the same rigorous regulatory standards and regulatory pathways as any drug product, unique properties that arise from the small size, large surface area, and polydispersity of nanomaterials may lead to additional scientific considerations when following current FDA guidelines and practices for drug evaluation. This review article will discuss these scientific considerations based on the experience with FDA-approved drug products containing nanomaterials.
authors: CDER/OPQ/SRS, FDA, Silver Springs, MD, USA.
authors: Katherine M
authors: KM
authors: Tyner
authors: CDER/OPQ/SRS, FDA, Silver Springs, MD, USA.
authors: Peng
authors: P
authors: Zou
authors: CDER/OPQ/SRS, FDA, Silver Springs, MD, USA.
authors: Xiaochuan
authors: X
authors: Yang
authors: CDER/OPQ/SRS, FDA, Silver Springs, MD, USA.
authors: Hailing
authors: H
authors: Zhang
authors: CDER/OPQ/SRS, FDA, Silver Springs, MD, USA.
authors: Celia N
authors: CN
authors: Cruz
authors: CDER/OPQ/SRS, FDA, Silver Springs, MD, USA.
authors: Sau L
authors: SL
authors: Lee
mesh_terms: D000818:Animals; D055598:Chemical Phenomena; D015195:Drug Design; D017408:Guidelines as Topic; D006801:Humans; D007880:Legislation, Drug; D049329:Nanostructures / Q000592:standards*; D012926:Social Control, Formal; D014481:United States