The nanomedicine revolution: Part 3: Regulatory and safety challenges

P and T

Volumn 37, Issue 11, 2012, Pages 631-639

  Lee Ventola, C ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

MACROGOL; NANOMATERIAL; NANOPARTICLE;

ABLATION THERAPY; ARTICLE; BIOCOMPATIBILITY; BRAIN EDEMA; CARCINOGENICITY; DRUG APPROVAL; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG EXCRETION; DRUG MANUFACTURE; DRUG RETENTION; DRUG SAFETY; DRUG SCREENING; ENVIRONMENTAL FACTOR; FOOD AND DRUG ADMINISTRATION; GENOTOXICITY; GOVERNMENT REGULATION; HEALTH CARE POLICY; HUMAN; NANOMEDICINE; NANOTECHNOLOGY; NEOPLASM; PACKAGING; PARTICLE SIZE; PHYSICAL CHEMISTRY; PHYSICAL PARAMETERS; POSTMARKETING SURVEILLANCE; PRACTICE GUIDELINE; RESEARCH; RISK ASSESSMENT; SIDE EFFECT;

EID: 84870680872     PISSN: 10521372     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (25)

1. Bawa R. Regulating nanomedicine: Can the FDA handle it? Curr Drug Deliv 2011;8(3):227-234.
2. Paradise J. The FDA, nanodrugs, and implications for healthcare. Presented at the American Society of Law, Medicine & Ethics 32nd Annual Health Law Professors Conference, Cleveland, June 5, 2009. Available at: www.tseed.com/aslme/conference/data/papers/013.pdf. Accessed September 4, 2012.
3. The Loka Institute. Principles for the Oversight of Nanotechnologies and Nanomaterials. July 31, 2007. International Center for Technology Assessment (ICTA). Available at: www.loka.org/Documents/nano_Principles_for_the_Oversight_of_Nanotechnologies_and_%20Nanomaterials_final.pdf. Accessed September 4, 2012.
4. Poirot-Mazères I. Legal aspects of the risks raised by nanotechnologies in the field of medicine. J Int Bioethique. 2011; 22(1):99-118, 212.
5. FDA, Science & Research. Nanotechnology Task Force Report 2007. Available at: www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/UCM2006659.htm. Accessed September 4, 2012.
6. FDA continues dialogue on 'nano' regulation. FDA Consumer Updates. Available at: www.fda.gov/ForConsumers/ConsumerUpdates/ucm258462.htm. Accessed September 4, 2012.
7. Fact Sheet: Nanotechnology. FDA Guidance Documents. Available at: www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ucm300914.htm. Accessed September 4, 2012.
8. FDA's approach to regulation of nanotechnology products. FDA Science & Research. Available at: www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm301114.htm. Accessed September 4, 2012.
9. Bawa R. Nanoparticle-based therapeutics in humans: A survey. Nanotechnol Law Business 2008;5(2):135-155.
10. Vaddiraju S, Tomazos I, Burgess DJ, et al. Biosens Bioelectron Emerging synergy between nanotechnology and implantable biosensors: A review. 2010;25(7):1553-1565.
11. Kim B, Rutka JT, Chan W. Nanomedicine. N Engl J Med 2010; 363:2434-2443.
12. Morigi V, Tocchio A, Pellegrini CB. Nanotechnology in medicine: From inception to market domination. J Drug Deliv (March 7, 2012.).
13. Galvin P, Thompson D, Ryan KB, et al. Nanoparticle-based drug delivery: Case studies for cancer and cardiovascular applications. Cell Mol Life Sci 2012;69(3):389-404.
14. Bharali DJ, Mousa SA. Emerging nanomedicines for early cancer detection and improved treatment: Current perspective and future promise. Pharmacol Ther 2010;128(2):324-335.
15. Seigneuric R, Markey L, Nuyten DS, et al. From nanotechnology to nanomedicine: Applications to cancer research. Curr Mol Med 2010;10(7):640-652.
16. Fact Sheet: FDA Nanotechnology Task Force Report outlines scientific, regulatory challenges (FDA Consumer Updates). July 4, 2012. Available at: www.fda.gov/ForConsumers/ConsumerUpdates/ucm110934.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=nanomedicine&utm_content=1. Accessed September 4, 2012.
17. FDA, Science & Research: FDA readies for more nanoscale challenges. Available at: www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm153723.htm. Accessed September 4, 2012.
18. FDA Regulatory Information. Considering whether an FDAregulated product involves the application of nanotechnology: Guidance for industry. June 2011. Available at: www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm. Accessed September 4, 2012.
19. Current Medical Applications. The Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars. Available at: www.nanotechproject.org/inventories/medicine/apps. Accessed September 4, 2012.
20. Draft guidelines for nanomedicines unveiled. Nature (September 28, 2011, online). Available at: www.nature.com/news/2011/110928/full/news.2011.562.html. Accessed September 4, 2012.
21. FDA, Science & Research: Nanotechnology Task Force, July 23, 2012. Available at: www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm2006658.htm. Accessed September 4, 2012.
22. FDA, Science Board Advisory Committee Meeting, March 31, 2006. Available at: www.fda.gov/ohrms/dockets/ac/06/transcripts/2006_4211t.pdf. Accessed September 4, 2012.
23. National Nanotechnology Initiative Supplement to the President's 2012 Budget. Available at: www.nano.gov/sites/default/files/pub_resource/nni_2012_budget_supplement.pdf?q=NNI_2012_budget_supplement.pdf. Accessed September 4, 1012.
24. Sajja HK, East MP, Mao H, et al. Development of multifunctional nanoparticles for targeted drug delivery and noninvasive imaging of therapeutic effect. Curr Drug Discov Technol 2009;6(1):43-51.
25. NCI Alliance for Nanotechnology in Cancer, Missions and Goals. Available at: http://nano.cancer.gov/about. Accessed February 4, 2012.