Big Things Come in Small Packages: FDA’s Approach to Nanotechnology

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:

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
  • 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:

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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The opinions and analysis expressed in this post reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this post is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This post is not intended to endorse any company or product and should not be attributed as such.

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