- August 13, 2020
- Organized By:
About the Presentation:
Nanotechnology is the control of matter at the nanoscale, where unique phenomena and unusual properties enable novel applications. Nanomaterials are incorporated in many FDA regulated products, utilizing the unique advantages they offer, such as increased sensitivity of detection of biomarkers for early disease detection and diagnosis, generation of safer drug formulations and novel medical devices. Anticipating an increase in submissions to FDA of products that involve the application of nanotechnology, the then acting commissioner launched the Nanotechnology Task Force (NTF) in 2006. The mission of the NTF is to assess the state of science, provide recommendations to improve the FDA’s scientific knowledge of nanotechnology and to address the regulatory challenges with products that use nanotechnology. Since then, the FDA has set up laboratory infrastructure, conducted regulatory science research, provided training to reviewers and scientific staff, issued draft and final guidance documents to support innovative development of beneficial nanotechnology products, and collaborated with other agencies and stake holders to promote responsible development of nanotechnology to advance public health. The immense amount of research from dedicated grant funding in nanotechnology through the National Nanotechnology Initiative over the past two decades has resulted in greater understanding of nanotechnology and nanomaterial. It contributed to our understanding of nanomaterial critical quality attributes that contribute to the safety, biocompatibility and efficacy. As anticipated, these advances have resulted in a gradual increase of submission of products containing nanotechnology to FDA, over 600 drug products to date, many approved for clinical use. The FDA continues to monitor the scientific and technological advancements and the convergence of emerging technologies with nanotechnology to prepare its work force in responding to submissions through regulatory review.
This seminar is aimed at presenting the Nanotechnology Task Force report on the progress FDA made in nanotechnology since 2007. It will include the basics of nanotechnology, highlight the facilities, regulatory science research, guidance documents, standards, domestic and international collaborations, and emerging challenges in regulatory science.
Disclaimer: The views expressed in this presentation do not necessarily represent those of the U.S. Food and Drug Administration
About the Speaker:
Anil K. Patri, Ph.D.
Chair, Nanotechnology Task Force
Director, Nanocore, NCTR/FDA
Dr. Anil Patri serves as the Chair, Nanotechnology Task, and as the Director of Nanocore, National Center for Toxicological Research, US Food and Drug Administration (US FDA). Nanocore conducts nanotechnology regulatory science research to understand material characteristics, what parameters contribute to their safety, and efficacy through internal research projects. Nanocore also offers staff training and develops consensus standards through stakeholder collaboration. Dr. Patri serves on the U.S. National Nanotechnology Initiative (NNI) NSET Subcommittee and NEHI working group for US government inter-agency coordination. He is as member of ISO TC229 and serves on the executive committee of ASTM E56 to facilitate standards development. He served on journal editorial and scientific advisory boards.
Prior to joining FDA in 2014, Dr. Patri served as the Deputy Director, Nanotechnology Characterization Laboratory (NCL) at the Frederick National Laboratory for Cancer Research. In a decade long tenure at NCL, he managed over 85 projects for the preclinical evaluation of nanomaterial for cancer. He developed nanotechnology-based targeted drug delivery and imaging agents until 2004 at the University of Michigan Medical School. He is a synthetic chemist by training and earned his Ph.D., in Chemistry from the University of South Florida.
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