Nanotechnology: A regulatory perspective
While many definitions for nanotechnology exist, the National Nanotechnology Initiative (NNI, Washington, DC,
http://www.nano.gov/), a federal research and development program established to coordinate the multiagency efforts in nanoscale science, engineering,
and technology, in which the US Food and Drug Administration (Rockville, MD,
http://www.fda.gov/) and 22 other federal agencies participate, specifies that nanotechnology involves: research and technology development at the atomic, molecular, or macromolecular levels, in the length scale of
approximately 1–100 nm; creating and using structures, devices, and systems that have novel properties and functions because
of their small and/or intermediate size; and the ability to control or manipulate on the atomic scale (3).
The FDA has not established its own formal definition for nanotechology, although the agency participated in the development
of the NNI definition of nanotechnology. Using that definition, nanotechnology relevant to FDA might include research and technology development that both satisfies
the NNI definition and relates to a product regulated by FDA (3).
To facilitate the regulation of nanotechnology products, FDA formed a NanoTechnology Interest Group (NTIG), which is made
up of representatives from all agency's centers (3).
The growing importance of nanotechnolgy in pharmaceuticals was underscored last year by FDA launching the Nanotechnology Task
Force, whose mission is to identify and recommend ways to address knowledge or policy gaps to facilitate the safe and effective
use of nanoengineered materials in FDA-regulated products. The task force held its first public meeting last October (4),
and a report from that meeting is due this year (5).
In 2005, under the National Cancer Institute's (NCI) Alliance for Nanotechnology in Cancer, a initiative encompassing the
public and private sectors and designed to accelerate the application of the best capabilities of nanotechnology to cancer,
FDA and NCI joined forces under the nano-subcommittee of the Interagency Oncology Task Force (IOTF). Under the IOTF umbrella,
FDA, NCI, and now NIST, are leveraging resources and expertise to advance nanotechnology in the context of oncology (5).
1. D. Discher, "Shape Effects of Filaments Versus Spherical Particles in Flow and Drug Delivery," Nature Nanotechnology 2 (4), 249–255 (2007).
2. S. Rana et al., "On the Suitability of Nanocrystalline Ferrites as a Magnetic Carrier for Drug Delivery: Functionalization, Conjugation
and Drug Release Kinetics," Acta Biomater 3 (2), 233–242 (2007).
3. FDA , "FDA and Nanotechology Products,"
http://www.fda.gov/nanotechnology/faqs.html, accessed May 7, 2007.
4. FDA, "Public Meeting on Nanotechnology Materials in FDA-Regulated Products (USFood and Drug Administration Nanotechnology
Task Force, Bethesda, MD), Oct. 2006,
http://www.fda.gov/nanotechnology/meetings/transcript.html, accessed May 7, 2007.
5. FDA, "Did You Know: Nanotechnology,"
http://www.fda.gov/oc/initiatives/criticalpath/nanotechnology.html, accessed May 7, 2007.