By a News Reporter-Staff News Editor at Drug Week -- Investigators publish new report on Nanotechnology. According to news reporting originating from Silver Spring, Maryland, by NewsRx correspondents, research stated, "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."
Our news editors obtained a quote from the research from Center for Drug Evaluation and Research, "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."
According to the news editors, the research concluded: "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."
For more information on this research see: CDER risk assessment exercise to evaluate potential risks from the use of nanomaterials in drug products. The Aaps Journal [electronic Resource], 2013;15(3):623-8. The Aaps Journal [electronic Resource] can be contacted at: Springer, 233 Spring Street, New York, NY 10013, USA (see also technology.html">Nanotechnology).
The news editors report that additional information may be obtained by contacting C.N. Cruz, Center for Drug Evaluation and Research, United States Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, United States. Additional authors for this research include K.M. Tyner, L. Velazquez, K.C. Hyams, A. Jacobs, A.B. Shaw, W. Jiang, R. Lionberger, P. Hinderling, Y. Kong, P.C. Brown, T. Ghosh, C. Strasinger, S. Suarez-Sharp, D. Henry, M. Van Uitert, N. Sadrieh and E. Morefield.
Publisher contact information for the The Aaps Journal [electronic Resource] is: Springer, 233 Spring Street, New York, NY 10013, USA.
Keywords for this news article include: Maryland, Silver Spring, United States, Nanotechnology, Emerging Technologies, North and Central America.
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