1. CDER Risk Assessment Exercise to Evaluate Potential Risks from the Use of Nanomaterials in Drug Products
- Author
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Paul Brown, Robert Lionberger, Arthur B. Shaw, Kenneth C. Hyams, Don Henry, Celia N. Cruz, Abigail Jacobs, Nakissa Sadrieh, Lydia Velazquez, Tapash Ghosh, Peter H. Hinderling, Caroline Strasinger, Sandra Suarez-Sharp, Elaine Morefield, Wenlei Jiang, Yoon Kong, Katherine M. Tyner, and Maat Van Uitert
- Subjects
Drug ,Active ingredient ,business.industry ,media_common.quotation_subject ,Pharmaceutical Science ,Pharmacy ,Pharmacology ,Regulatory Note ,Risk Assessment ,United States ,Impact of nanotechnology ,Nanostructures ,Food and drug administration ,Risk analysis (engineering) ,Pharmaceutical Preparations ,Medicine ,Drug Evaluation ,Humans ,business ,Risk assessment ,Management process ,Drug Approval ,Risk management ,media_common - 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.
- Published
- 2013