The Office of the Commissioner, in partnership with the FDA Nanotechnology Task Force, facilitates communication and cooperation across the agency on nanotechnology regulatory science research, both within FDA and with national and international stakeholders. The FDA Nanotechnology Task Force provides the overall coordination of FDA’s nanotechnology regulatory science research efforts in the following programmatic investment areas:
- Supporting Nanotechnology Core Facilities
Nanotechnology Core Facilities provide for laboratory testing capacity at FDA. In line with the FDA Nanotechnology Task Force report of July 2007, top tier priorities consist of: (1) Developing testing methods to assess the safety of products that use nanomaterials (including their stability and interaction with biological systems); (2) Developing testing methods to assess the quality and effectiveness of products that use nanomaterials; and (3) Developing standards to be incorporated in the safety assessment of products that contain nanomaterials or otherwise involve the application of nanotechnology.
- Enhancing Staff Training and Professional Development
FDA has established a program to train staff to evaluate the scientific data submitted in support of regulatory applications that involve nanotechnology. Course work covers: (1) Cooperative training and research work within FDA, at national laboratories, and at government sponsored research centers; (2) FDA activities that engage and allow for information exchange and coordination with stakeholders, other government agencies, and international counterparts; and (3) Strengthening FDA nanotechnology scientific staff training and professional development opportunities.
- Collaborative Opportunities for Research Excellence in Science (CORES) Program
There are many types of products where the FDA is currently the only federal agency to conduct research essential to inform science-based regulatory decisions, such as those related to safety and/or risk assessments. While the agency can undertake some self-initiated research, the scale and range of issues and expertise involved necessitate collaborations with academic and government laboratories. FDA has established a Nanotechnology CORES Program to foster collaborative and interdisciplinary research addressing product characterization and safety. The nanotechnology CORES program supports peer reviewed research at FDA, in collaboration with academia and government stakeholders.
For further information:
Office of the Chief Scientist-Nanotechnology
Food and Drug Administration
FDA White Oak Campus
10903 New Hampshire Avenue
Silver Spring, MD 20993