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Product quality for nanomaterials: current U.S. experience and perspective
Author(s) -
Tyner Katherine M.,
Zou Peng,
Yang Xiaochuan,
Zhang Hailing,
Cruz Celia N.,
Lee Sau L.
Publication year - 2015
Publication title -
wiley interdisciplinary reviews: nanomedicine and nanobiotechnology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.175
H-Index - 72
eISSN - 1939-0041
pISSN - 1939-5116
DOI - 10.1002/wnan.1338
Subject(s) - nanotechnology , nanomaterials , drug , food and drug administration , drug delivery , product (mathematics) , risk analysis (engineering) , medicine , pharmacology , materials science , geometry , mathematics
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. WIREs Nanomed Nanobiotechnol 2015, 7:640–654. doi: 10.1002/wnan.1338 This article is categorized under: Biology-Inspired Nanomaterials > Protein and Virus-Based Structures