Regulatory Challenges in Biomaterials: Focus on Medical Devices - Biomaterials Science: An Integrated Clinical and Engineering Approach - page 259

Nanotechnology Regulation
In spite of this tremendous potential of nanoparticles for drug delivery
(among other applications), there has been a call for a tight control (including
prohibition, moratorium, and the use of the precautionary principle) over
nanotechnology products. This could be explained by the increasing con-
cerns about the toxicological and environmental fate of nanoparticles and
their social and ethical consequences. Some of these concerns are that the
same features that make nanoparticles an attractive platform for drug deliv-
ery systems (e.g., passage through the blood-brain barrier) could promote
toxicity issues, and that more studies should be carried out before any prod-
uct enters the market [73, 75, 76].
In order to afford these challenges, the FDA has embarked on a series of
public-private collaborations, including the Nanotechnology Characterization
Laboratory (NCL), which was created in collaboration with the National
Institute of Standards and Technology (NIST) and the National Cancer
Institute (NIC), in order to perform preclinical assessment of nanotechnol-
ogy products for cancer therapy, including physical, chemical, and biological
characterization of nanoparticles. Companies are encouraged to request the
from NCL a complete characterization process for their products. In this man-
ner, there is a mutual benefit between regulators and the industry. In addition
to the NCL, the National Center for Toxicological Research (NCTR) is carry-
ing out several projects to better understand the toxicological implications of
nanoparticle-based products. Among these projects are the following:
a) Nanotube-based technologies: their implications in public health
b) Skin penetration of quantum dots (nanocrystal semiconductor
particles)
c) Tumorigenicity of titanium dioxide nanoparticles
d) Neurotoxicity of manganese nanoparticles
e) Neurotoxicity of silver nanoparticles
f) Application of electron spin resonance spectroscopy to gain more
insights into the interaction of nanoparticles with biological systems
The FDA has established other external collaborations, including with
John Hopkins Hospital and the Houston Nanohealth Initiative. In addi-
tion to external collaborations, the FDA has been engaged in developing
an internal expert group in nanotechnology. In August 2006, the FDA cre-
ated the Nanotechnology Task Force, which, among its duties, has to find
the adequate pathways to regulate nanotechnology products. The creation
of a Nanotechnology Task Force at the FDA allowed the agency to have the
tools for reviewing and/or characterizing nanotechnology-based products,
with the authority to request information from nanotechnology manufactur-
ers about formulations, including the use of nanoscale material, and proof