CDER Risk Assessment Exercise to Evaluate Potential Risks from the Use of Nanomaterials in Drug Products

• Published in: The AAPS journal Vol. 15; no. 3; pp. 623 - 628
• Main Authors: Cruz, Celia N., Tyner, Katherine M., Velazquez, Lydia, Hyams, Kenneth C., Jacobs, Abigail, Shaw, Arthur B., Jiang, Wenlei, Lionberger, Robert, Hinderling, Peter, Kong, Yoon, Brown, Paul C., Ghosh, Tapash, Strasinger, Caroline, Suarez-Sharp, Sandra, Henry, Don, Van Uitert, Maat, Sadrieh, Nakissa, Morefield, Elaine
• Format: Journal Article
• Language: English
• Published: Boston Springer US 01.07.2013
• Subjects: Biochemistry; Biomedical and Life Sciences; Biomedicine; Biotechnology; Drug Approval - methods; Drug Evaluation - methods; Drug Evaluation - standards; Humans; Nanostructures - adverse effects; Nanostructures - standards; Pharmaceutical Preparations - standards; Pharmacology/Toxicology; Pharmacy; Regulatory Note; Risk Assessment - methods; Risk Assessment - standards; United States; United States; nanotechnology; CDER; nanomaterial; risk assessment; risk management
• ISSN: 1550-7416; 1550-7416
• DOI: 10.1208/s12248-013-9466-6

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.