Nanomedicine: Nanotechnology, Biology and Medicine
Volume 2, Issue 2 , Pages 127-136 , June 2006

Bringing nanomedicines to market: regulatory challenges, opportunities, and uncertainties

  • Ruchika Nijhara, PhD

      Affiliations

    • University of Maryland, Office of Research and Development, Baltimore, MD, United States
  • ,
  • Krishna Balakrishnan, PhD, MBA

      Affiliations

    • National Institutes of Health, Foundation for Advanced Education in the Sciences, Bethesda, MD 20814, United States
    • Corresponding Author InformationCorresponding author. One Cloister Court, Suite 230 Bethesda, MD 20814.

Received 17 February 2006 ,Accepted 8 April 2006.

References 

  1. Zajtchuk R. New technologies in medicine: biotechnology and nanotechnology. Disease-a-Month. 1999;45(11):453–495
  2. The impact of nanotechnology in drug delivery: global developments, market analysis and future prospects. Market Research Reports by Nanomarkets. 2005;February
  3. Sara Fernandez-Lopez S, Kim H-S, Choi EC, Delgado M, Granja JR, Khasanov A, et al. Antibacterial agents based on the cyclic d,l-α-peptide architecture. Nature. 2001;412:452–455
  4. McDevitt MR, Ma D, Lai LT, Simon J, Borchardt P, Frank RK, et al. Tumor therapy with targeted atomic nanogenerators. Science. 2001;294(5546):1537–1540
  5. Voss D. Nanomedicine nears the clinic. Tech Rev. 2000;103:60–65
  6. Philipkoski K. Tiny Capsules Float Downstream. Oct. 29, Wired News. 2001;http://www.memagazine.org/backissues/aug01/features/nmeter/nmeter.html
  7. Wierenga DE, Eaton CR. Office of Research and Development, Pharmaceutical Manufacturers Association. http://www.allp.com/drug_dev.htm.
  8. Meadows M. The FDA's drug review process: ensuring drugs are safe and effective. FDA Consumer Magazine. 2002;
  9. O'Reilly JT. Food and Drug Administration § 18.05. 2nd ed. 1995.
  10. U.S.C § 360(a)(1)(B)(2000).
  11. http://www.fda.gov/cder/handbook/.
  12. www.fda.gov/nanotechnology/ ChBSA-nanotech-presentation06-04.ppt.
  13. www.fda.gov/nanotechnology/Regulatory_Perspective.ppt.
  14. Till MC, Simkin MM, Marbius S. Nanotech meets the FDA: A success story about the first nanoparticulate drugs approved by the FDA. Nanotechnology Law and Business. 2005;2.2:163–167www.efoley.com/files/tbl_s31Publications%5CFileUpload137%5C2007%5C1180354_1.pdf
  15. 21 U.S.C §§ 332-34.
  16. 21 U.S.C §§ 374.
  17. 21 C.F.R § 211.25 (a).
  18. 21 C.F.R § 820.25 (a).
  19. 21 C.F.R § 211.72 (2003).
  20. 21 C.F.R § 211.65 (a).
  21. 21 C.F.R § 820.70 (c).
  22. 21 C.F.R § 211.72.
  23. Sampson MT. Type of buckyball shown to cause brain damage in fish. Eurekalert. www.eurekalert.org.
  24. ETC Group Genotype. Nano's troubled waters: Latest toxic warning shows nanoparticles cause brain damage in aquatic species and highlights need for a moratorium on the release of new nanomaterials. 2004; www.etcgroup.org.
  25. ETC Group. Size matters! The case for a global moratorium. Occasional Paper Series. 2003;7(1):www.etcgroup.org
  26. Kirby A. Tiny particles threaten brain. BBC News Online. 2004; Jan 8. http://news.bbc.co.uk/1/hi/sci/tech/3379759.stm.
  27. Miller J. The Columbia, Science and Technology Law Review. www.stlr.org.
  28. Safe Medical Devices Act of 1990, Pub. L. No. 101-629. §16, 104 Stat. 4511, 4526 (codified as amended at 21 U.S.C. § 353 (1994).
  29. Schwetz BA, Homire SA, MacGregor JT. Science at the FDA: Improving the scientific basis of regulation through collaboration with “stakeholders‬”. The Pharmacologist. 1999;41(1):9–10
  30. Wyeth Financial Report 2005 http://phx.corporate-ir.net/phoenix.zhtml?c=78193&p=irol-.
  31. Harris M, Ellis P, Harper P. Nanoparticle albumin–bound Paclitaxel for metastatic breast cancer. J Clin Oncol. 2005;23(31):7768–7771http://www.elan.com/news/full.asp?ID=702431
  32. Key to improved chemotherapy response to Abraxane™ validated by clinical data. November 3, Abraxis Pharmaceuticals News Release. 2005;http://www.appdrugs.com/PressDetailText.cfm?ID=778241
  33. FDA approves Abraxane™, first in new class of protein-bound particle drugs for metastatic breast. Jan. 7, PRNewswire. 2003;http://www.appdrugs.com/050405PR.html
  34. Tricor–Drug approved by FDA. http://www.centerwatch.com/patient/drugs/dru723.html. http://biz.yahoo.com/e/050510/appx10-q.html.
  35. Avinza–Drug approved by FDA. http://www.centerwatch.com/patient/drugs/dru768.html. http://www.centerwatch.com/cgi-bin/cl.pl?p=patient/drugs/dru36.html.
  36. Elan and EntreMed execute license agreement for proprietary NanoCrystal® technology. http://www.elan.com/news, January 10, 2006. http://www.elan.com/News/full.asp?ID=271635.
  37. Nanotechnology in Ireland: A snapshot. Irish Council for Science, Technology and Innovation. http://www.forfas.ie/icsti. http://www.emend.com/aprepitant/emend/consumer/index.jsp.

PII: S1549-9634(06)00045-1

doi: 10.1016/j.nano.2006.04.005

Nanomedicine: Nanotechnology, Biology and Medicine
Volume 2, Issue 2 , Pages 127-136 , June 2006