Summary Report of PQRI Workshop on Nanomaterial in Drug Products: Current Experience and Management of Potential Risks

Author:

Bartlett Jeremy A.,Brewster Marcus,Brown Paul,Cabral-Lilly Donna,Cruz Celia N.,David Raymond,Eickhoff W. Mark,Haubenreisser Sabine,Jacobs Abigail,Malinoski Frank,Morefield Elaine,Nalubola Ritu,Prud’homme Robert K.,Sadrieh Nakissa,Sayes Christie M.,Shahbazian Hripsime,Subbarao Nanda,Tamarkin Lawrence,Tyner Katherine,Uppoor Rajendra,Whittaker-Caulk Margaret,Zamboni William

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference98 articles.

1. PQRI Workshop: Nanomaterial in Drug Products Current Experience and Risk Management. January 14–15, 2014, USP Meeting Center, Rockville, MD. Final Program Agenda at: http://www.pqri.org/workshops/Nanomaterials2013/Final.Program.Agenda.pdf . Accessed 21 Aug 2014.

2. Cruz CN, Tyner KM, Velezquez L, Hyams K, Jacobs A, Shaw A, et al. CDER risk assessment exercise to evaluate potential risks from the use of nanomaterials in drug products. AAPS J. 2013;15(3):623–8. doi: 10.1208/s12248-013-9466-6 .

3. FDA’s approach to regulation of nanotechnology products. Available online at: http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm301114.htm ; see also Hamburg, 2012. Science 336:299–300. Accessed 21 Aug 2014.

4. Office of Science and Technology Policy, Office of Management and Budget, and the United States Trade Representative. Principles for regulation and oversight of emerging technologies, March 11, 2011; available online at: http://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/Principles-for-Regulation-and-Oversight-of-Emerging-Technologies-new.pdf . Accessed 21 Aug 2014.

5. Office of Science and Technology Policy, Office of Management and Budget, and the United States Trade Representative. Policy principles for the U.S. decision-making concerning regulation and oversight of applications of nanotechnology and nanomaterials, June 9, 2011; available online at: http://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/nanotechnology-regulation-and-oversight-principles.pdf . Accessed 21 Aug 2014.

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