FDA's approach to regulation of products of nanotechnology

Science

Volumn 336, Issue 6079, 2012, Pages 299-300

  Hamburg, Margaret A ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

COSMETIC; FOOD ADDITIVE; NANOMATERIAL;

ADVANCED TECHNOLOGY; NANOTECHNOLOGY; RESEARCH AND DEVELOPMENT; SCIENCE AND TECHNOLOGY; UNCERTAINTY ANALYSIS;

DIET SUPPLEMENTATION; DRUG EFFICACY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE QUALITY; HUMAN; LEGAL ASPECT; NANOTECHNOLOGY; PHYSICAL CHEMISTRY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PROCESS MONITORING; PUBLIC HEALTH SERVICE; REVIEW; RISK; ARTICLE; DRUG APPROVAL; GOVERNMENT REGULATION; POLICY; PRODUCT SAFETY; UNITED STATES;

CONSUMER PRODUCT SAFETY; COSMETICS; DRUG APPROVAL; GOVERNMENT REGULATION; NANOSTRUCTURES; NANOTECHNOLOGY; PRODUCT SURVEILLANCE, POSTMARKETING; PUBLIC POLICY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84859950790     PISSN: 00368075     EISSN: 10959203     Source Type: Journal    
DOI: 10.1126/science.1205441     Document Type: Review

References (22)

1. For more information about FDA regulations, including between pre- and postmarket approval, review, and notification, see www.fda.gov/AboutFDA/ Transparency/Basics/ default.htm.
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4. Scientific Committee on Emerging and Newly Identifi ed Health Risks, Scientific Basis for the Definition of the Term "Nanomaterial" (EC, Brussels, 2010); http:// ec.europa.eu/health/scientific-committees/emerging/ docs/scenihr-o-030.pdf.
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8. FDA, Considering whether an FDA-regulated product involves the application of nanotechnology: Guidance for industry; www.fda.gov/ RegulatoryInformation/Guidances/ucm257698.htm.
9. Nanotechnology Task Force Report 2007; www.fda.gov/ ScienceResearch/ SpecialTopics/Nanotechnology/ NanotechnologyTaskForceReport2007/default.htm.
10. FDA, Nanotechnology Regulatory Science Research Categories, www.fda.gov/ScienceResearch/SpecialTopics/ Nanotechnology/ucm196697.htm.
11. NNI, www.nano.gov/about-nni.
12. NNI, Capstone meeting: Risk management methods and ethical, legal, and societal implications of nanotechnology, Arlington, VA, 30 to 31 March 2010; www.nano.gov/ events/meetings-workshops/capstone.
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14. EC, Directive on cosmetics; http://eur-lex.europa.eu/ LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059: 0209:en:PDF.
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19. T. Earles, Office of Science and Technology, Emerging technologies committee lays out principles for guidance; www.whitehouse.gov/blog/2011/03/16/ emerging-technologies- committee-lays-out-principles-guidance.
20. J. P. Holdren, C. R. Sustein, I. A. Siddiqui, Policy Principles for the U.S. decision-making concerning regulation and oversight of applications of nanotechnology and nanomaterials [memorandum] (Executive Offices, Washington, DC, 2011); www.whitehouse.gov/sites/ default/files/omb/inforeg/for-agencies/ nanotechnology-regulation- and-oversight-principles.pdf.
21. FFDCA § 409 (21 U.S.C. 348) and 21 CFR 170.3(i).
22. FFDCA § 505 (21 U.S.C. 355) and § 512 (21 U.S.C. 360b).