title: CDER risk assessment exercise to evaluate potential risks from the use of nanomaterials in drug products.
abstract: The Nanotechnology Risk Assessment Working Group in the Center for Drug Evaluation and Research (CDER) within the United States Food and Drug Administration was established to assess the possible impact of nanotechnology on drug products. The group is in the process of performing risk assessment and management exercises. The task of the working group is to identify areas where CDER may need to optimize its review practices and to develop standards to ensure review consistency for drug applications that may involve the application of nanotechnology. The working group already performed risk management exercises evaluating the potential risks from administering nanomaterial active pharmaceutical ingredients (API) or nanomaterial excipients by various routes of administration. This publication outlines the risk assessment and management process used by the working group, using nanomaterial API by the oral route of administration as an example.
authors.affiliation: Center for Drug Evaluation and Research, United States Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA.
authors.forename: Celia N
authors.initials: CN
authors.lastname: Cruz
authors.forename: Katherine M
authors.initials: KM
authors.lastname: Tyner
authors.forename: Lydia
authors.initials: L
authors.lastname: Velazquez
authors.forename: Kenneth C
authors.initials: KC
authors.lastname: Hyams
authors.forename: Abigail
authors.initials: A
authors.lastname: Jacobs
authors.forename: Arthur B
authors.initials: AB
authors.lastname: Shaw
authors.forename: Wenlei
authors.initials: W
authors.lastname: Jiang
authors.forename: Robert
authors.initials: R
authors.lastname: Lionberger
authors.forename: Peter
authors.initials: P
authors.lastname: Hinderling
authors.forename: Yoon
authors.initials: Y
authors.lastname: Kong
authors.forename: Paul C
authors.initials: PC
authors.lastname: Brown
authors.forename: Tapash
authors.initials: T
authors.lastname: Ghosh
authors.forename: Caroline
authors.initials: C
authors.lastname: Strasinger
authors.forename: Sandra
authors.initials: S
authors.lastname: Suarez-Sharp
authors.forename: Don
authors.initials: D
authors.lastname: Henry
authors.forename: Maat
authors.initials: M
authors.lastname: Van Uitert
authors.forename: Nakissa
authors.initials: N
authors.lastname: Sadrieh
authors.forename: Elaine
authors.initials: E
authors.lastname: Morefield
mesh_terms: D017277:Drug Approval / Q000379:methods*; D004341:Drug Evaluation / Q000379:methods / Q000592:standards; D006801:Humans; D049329:Nanostructures / Q000009:adverse effects / Q000592:standards*; D004364:Pharmaceutical Preparations / Q000592:standards*; D018570:Risk Assessment / Q000379:methods / Q000592:standards; D014481:United States
chemical_list: D004364:Pharmaceutical Preparations