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Nanotechnology Partnerships at FDA
FDA's Nanotechnology Task Force Report of 2007 called for promoting and participating in collaborative efforts, to further understanding of biological interactions of nanoscale materials, and exploring opportunities to enable innovation using nanoscale materials to develop safe and effective products under its regulatory jurisdiction. Aligned with the need to promote and participate in such collaborations whereby stakeholders can leverage expertise and resources to stimulate innovation in this field, FDA has embarked on a number of Public-Private Partnerships (PPPs) under its public health mission. This site is intended to provide, in a transparent way, both a synopsis of its current collaborations in the field of nanotechnology and an opportunity for stakeholders to either join with us to expand existing collaborations or embark upon new ones with FDA, in the interest of public health.
For more information about other federal agencies involved in nanotechnology, please visit the link to the National Nanotechnology Initiative web site.
The U.S. Food and Drug Administration (FDA) has partnered with the National Institute of Standards and Technology (NIST) and, the National Cancer Institute (NCI) to established the Nanotechnology Characterization Laboratory to perform preclinical efficacy and toxicity testing of nanoparticles. Other activities of this partnership include:
- Co-development of characterization assay cascades associated with NCI’s Nanotechnology Characterization Laboratory (NCL)
For more information about NCL’s operation, please refer to NCL's business plan
- Development of standardized approaches for evaluating nanoscale particles submitted to the NCL
- FDA providing scientific and regulatory input and guidance to the investigators and partners within the NCI’s Alliance for Nanotechnology in Cancer
FDA-Johns Hopkins University
This Memorandum of Understanding between the U.S. Food and Drug Administration ("FDA") and Johns Hopkins University (the "Parties") is established to develop collaboration in the areas of education, research, and outreach.
The objectives of this collaborative partnership include, development of a collaborative working relationship between the Parties, provision of exchange of graduate and undergraduate students, faculty, and personnel, for the purposes of advanced training and outreach, stimulation of cooperative activities, research, and information exchange in areas such as bioethics, development of training programs for FDA and potentially other Government agencies and industry in broad scientific areas such as biotechnology and bioethics, development of a broad-based collaboration in the area of nanotechnology, including, in particular, with the Institute of NanoBioTechnology at the Johns Hopkins University.
FDA-ANH NanoTechnology Initiative (FANTI)
FDA is engaged in a collaboration with the Houston-based Alliance for NanoHealth (ANH) and its eight member institutions to help speed development of safe and effective medical products in the emerging field of nanotechnology.
Under the FDA/ANH Nanotechnology Initiative, the FDA and ANH will work to expand knowledge of how nanoparticles behave and affect biologic systems, and to facilitate the development of tests and processes that might mitigate the risks associated with nanoengineered products. All outcomes from this public-private partnership will be placed in the public domain for the benefit of all stakeholders.