Advisory
Committee for Pharmaceutical Science
Nanotechnology:
An Awareness Topic
Nanotechnology is a very rapidly growing area
of science and is anticipated to lead to the development of many novel and
sophisticated applications in drug delivery systems. Historically, nanometer sized materials
(e.g., silver and gold colloids) have been used in medicine for many
years. Additionally, many current
pharmaceutical materials and drug delivery systems (e.g., micro-emulsions,
liposomes) have dimensions in the nanometer range. The safety and efficacy of these products are
currently being addressed adequately within the established regulatory
system. However, the extensive research
and development activities in nanotechnology are expected to lead to the
development of more complex drug delivery systems, drug-device combination
products, and other products regulated by the FDA. To ensure that FDA is ready to meet this
responsibility, a multi-disciplinary discussion group has been assembled at the
Agency level, within the Office of Commissioner. This group is proactively gauging the growth
of nanotechnology so as to anticipate the complexity of future submissions to
the FDA. As such, the Agency needs to
have in place adequate regulatory procedures to deal with the challenges of the
nascent technology.
The purpose of the brief discussion at the
April 2004 Advisory Committee is to share information on CDER/FDA activities
and emerging plans to address the regulatory needs of nanotechnology based products. At a future meeting of the Advisory Committee
we will plan to discuss and seek advice on our approach to address
nanotechnology based products.