Regulating Nanomedicine – Can the FDA handle it, Medicine, Page 1
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| Page content: Regulating Nanomedicine Can the FDA handle it? Raj Bawa**1, MS, PhD **Patent Agent, Bawa Biotechnology Consulting LLC, Ashburn, Virginia, USA; Adjunct Associate Professor, Biology Department, Rensselaer Polytechnic Institute, Troy, New York, USA; and Founding Director, American Society for Nanomedicine, Ashburn, Virginia, USA. Abstract There is enormous excitement and expectation surrounding the multidisciplinary field of nanomedicine the application of nanotechnology to healthcare which is already influencing the pharmaceutical industry, especially in the design, formulation and delivery of therapeutics. Currently, nanomedicine is poised at a critical stage wherein regulatory guidance in this area assumes priority in providing for clarity and legal certainty to manufacturers, policymakers, healthcare providers and the public. There are hundreds, if not thousands, of nanoproducts on the market for human use but little is known of their health risks and toxicity. Less is known of nanoproducts that are released in the environment and that come in contact with humans. These nanoproducts, whether they are a drug, device, biologic or combination of any of the above, are creating challenges for the Food and Drug Administration (FDA), as regulators struggle to accumulate data and formulate testing criteria to ensure development of safe and efficacious nanoproducts. Evidence continues to mount that many nanoproducts inherently posses novel size based properties and toxicity profiles. Yet, there is no specific law or mechanism for oversight of nanomedicine and the FDA continues to treat nanoproducts as substantially equivalent ("bioequivalent") to their bulk counterparts. This poses unique regulatory challenges for the FDA. Such regulatory uncertainty could negatively impact venture funding, stifle nanomedicine research and development (R&D) as well as erode public confidence and acceptance of nanoproducts. The endresult of this could be a delay or loss of commercialized nanoproducts. Whether the FDA eventually creates new regulations, tweaks existing ones or establishes a new regulatory Center to handle nanoproducts, at the moment it should at least look at nanoproducts on a casebycase basis. The FDA should not attempt regulation of nanomedicine by applying existing statutes; incorporating it into the current regulatory scheme is a poor idea. Regulation of nanomedicine must balance innovation and R&D with the principle of ensuring high public health protection and safety. Keywords: nanomedicine, Food and Drug Administration, FDA, regulation, nanoparticles, nanotherapeutics, nanoproduct, combination products, patents, safety, efficacy, commercialization 1 Correspondence: Dr. Raj Bawa, Bawa Biotechnology Consulting LLC, 21005 Starflower Way, Ashburn, Virginia 20147, USA (Tel: 703-582-1745; 703-723-0034; Fax: 571-223-1844; Email: bawa@bawabiotech.com). Copyright © 2010 Raj Bawa. All rights reserved. 1 | ||||||
