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

Nanomedicine: Nanotechnology, Biology, and Medicine

Volumn 2, Issue 2, 2006, Pages 127-136

  Nijhara, Ruchika ^a   Balakrishnan, Krishna ^b  

^a UNIVERSITY OF MARYLAND   (United States)

^b NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

Clinical trials; Commercialization; Marketing; Nanomedicine; Product development; Regulations

Indexed keywords

CLINICAL TRIALS; COMMERCIALIZATION; NANOMEDICINES;

LAWS AND LEGISLATION; MARKETING; NANOTECHNOLOGY; PRODUCT DEVELOPMENT;

MEDICINE;

ANTINEOPLASTIC AGENT; APREPITANT; FENOFIBRATE; MORPHINE SULFATE; NANOPARTICLE; NAPROXEN; NEW DRUG; PACLITAXEL; RAPAMYCIN; SILICON;

ADVERTIZING; ARTICLE; BREAST CANCER; BREAST METASTASIS; CHEMOTHERAPY INDUCED EMESIS; CHRONIC PAIN; CLINICAL RESEARCH; DRUG APPROVAL; DRUG DELIVERY SYSTEM; DRUG DESIGN; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; HUMAN; HYPERCHOLESTEROLEMIA; HYPERLIPIDEMIA; HYPERTRIGLYCERIDEMIA; INDUSTRIAL HYGIENE; KIDNEY GRAFT REJECTION; MEDICINE; NANOMEDICINE; NANOTECHNOLOGY; NAUSEA; OSTEOARTHRITIS; PHASE TRANSITION; PHYSICAL CHEMISTRY; RHEUMATOID ARTHRITIS;

ANIMALS; DRUG CARRIERS; HUMANS; MARKETING OF HEALTH SERVICES; NANOMEDICINE; UNCERTAINTY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 33745461665     PISSN: 15499634     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.nano.2006.04.005     Document Type: Article

References (37)

1. Zajtchuk R. New technologies in medicine: biotechnology and nanotechnology. Disease-a-Month 45 11 (1999) 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 E.C., Delgado M., Granja J.R., Khasanov A., et al. Antibacterial agents based on the cyclic d,l-α-peptide architecture. Nature 412 (2001) 452-455
4. McDevitt M.R., Ma D., Lai L.T., Simon J., Borchardt P., Frank R.K., et al. Tumor therapy with targeted atomic nanogenerators. Science 294 5546 (2001) 1537-1540
5. Voss D. Nanomedicine nears the clinic. Tech Rev 103 (2000) 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 M.C., Simkin M.M., and Marbius S. Nanotech meets the FDA: A success story about the first nanoparticulate drugs approved by the FDA. Nanotechnology Law and Business 2.2 (2005) 163-167. www.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 7 1 (2003). 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 B.A., Homire S.A., and MacGregor J.T. Science at the FDA: Improving the scientific basis of regulation through collaboration with "stakeholders". The Pharmacologist 41 1 (1999) 9-10
30. Wyeth Financial Report 2005 http://phx.corporate-ir.net/phoenix.zhtml?c=78193&p=irol-.
31. Harris M., Ellis P., and Harper P. Nanoparticle albumin-bound Paclitaxel for metastatic breast cancer. J Clin Oncol 23 31 (2005) 7768-7771. http://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.