We’ve all heard the term nanotechnology thrown around, but what does it actually mean? Nanotechnology is the use of materials that exist on the nanometer scale to solve a problem. Nanobiotechnology takes this one step further. As defined by the Johns Hopkins Institute for NanoBiotechnology “It is a field of research that seeks new solutions to health and environmental problems by combining physical sciences and engineering with life sciences and medicine at the molecular scale.”
FDA’s Role in Facilitating the use of Nanotechnology
To fulfill its mission to safeguard the public’s health, drive innovation, and ensure a clear understanding of FDA’s nanotechnology activities, the FDA is building regulatory science knowledge, facilitating collaborations and partnerships, and establishing a flexible, product-focused, science-based approach to the regulation of nanotechnologies.
The FDA has been involved with nanotechnology for nearly two decades. The agency formed the Nanotechnology Task Force in 2006 with the goal of defining regulatory frameworks that encourage the development of safe and effective medical nanobiotechnology. Moreover, FDA has strengthened its research infrastructure by establishing two core facilities to support regulatory science research involving nanotechnology:
- Nanotechnology Core Facility, Jefferson Laboratories, Arkansas
- A collaboration between National Center for Toxicological Research (NCTR), Office of Regulatory Affairs (ORA), and National Institute of Environmental Health Sciences (NIEHS) and National Toxicology Program (NTP)
- Advanced Characterization Facility, FDA Headquarters, Maryland
- A collaboration between Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Food Safety and Applied Nutrition (CFSAN)
FDA Partnerships Spur Nanotechnology Innovations
The FDA also collaborates with other domestic agencies including:
- The National Nanotechnology Initiative (NNI)
- The Nanoscale Science Engineering and Technology (NSET) subcommittee
- The Nanotechnology Environmental and Health Implications (NEHI) working group
To participate in collaborations to stimulate innovation in this field, FDA has embarked on a number of Public-Private Partnerships (PPPs). This includes the following collaborations:
- Nanotechnology Characterization Laboratory
- FDA- National Cancer Institute (NCI)- National Institute of Standards and Technology (NIST) to create the Nanotechnology Characterization Laboratory (NCL) in order to perform multidisciplinary testing necessary for implementation of nanomedicine prospects.
- FDA- Johns Hopkins University Institute of NanoBioTechnology
- The Memorandum of Understanding between the agency and Johns Hopkins University was created to encourage collaboration in education, research, and outreach. In particular, FDA works closely with the Institute of NanoBioTechnology at Johns Hopkins University.
- FDA-ANH Nanotechnology Initiative (FANTI)
- FDA collaborates with the Alliance for NanoHealth (ANH) and its members to aid in the development of safe and effective medical devices using nanotechnology.
Outside of the US, the FDA works with international regulatory agencies to share perspectives on the regulation of nanotechnology. The Agency also participates in global forums including:
- International Organization for Standardization (ISO)
- Organisation for Economic Co-operation and Development (OECD)
- ASTM International
In Brief
Nanotechnology is an ever-growing field with unimaginable potential. With its numerous partnerships and nearly two decades of experience in the field, the FDA is thoroughly prepared to regulate safe uses of Nanotechnology within the US.
If big things come in small packages, imagine how large of an impact a package at the nanoscale can have!
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