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) partnered with the National Institute of Standards and Technology (NIST) and the National Cancer Institute (NCI) to establish the Nanotechnology Characterization Laboratory (NCL) to perform multidisciplinary testing, vital to the clinical translation of nanomedicine candidates. Under this partnership, NCL:
- Provides preclinical and early clinical characterization, pharmacokinetic, efficacy, and toxicity testing on a wide variety of nano-based formulations to support regulatory decision-making
- Protocols are freely available online
- Data acquired by NCL can be used to meet regulatory requirements for an Investigational New Drug (IND) or Investigational Device Exemption (IDE) filing
- Collaborates with FDA to design novel assays and assessment tools that complement regulatory evaluation and guidance development
- Performs research and development on nanomedicines, including mechanistic studies, bioanalytical/physicochemical methods development, and nanotech reformulation
FDA provides scientific input and guidance to the NCL on unmet regulatory needs, and serves on the NCL’s Scientific Oversight Committee.
To learn more about NCL, visit: https://ncl.cancer.gov/
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.