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FDA-ANH Program

The Food & Drug Administration (FDA) is gaining momentum in its strategic partnership with the Alliance for NanoHealth and the members of the ANH, which comprises eight (8) world renowned academic institutions in the Greater Houston, Texas Region.

This new collaboration is called the FDA-ANH Nanotechnology Initiative (FANTI). The Alliance institutions include: Baylor College of Medicine (BCM), William Marsh Rice University (Rice), University of Houston (UH), The University of Texas M. D. Anderson Cancer Center (UTMDACC), The University of Texas Medical Branch at Galveston (UTMB), The University of Texas Health Science Center at Houston (UTHSC-H), and Texas A&M Health Science Center (TAMHSC) and The Methodist Hospital Research Institute (TMHRI). 

The overarching goal of FANTI is to develop a framework of collaboration—that will include stakeholders from industry (pharmaceutical, biotech and devices), non-profit organizations, government and others—to work pre-competitively in identifying high priority scientific and translational gaps in moving nanoengineered medical products from preclinical stages of development through clinical stages and then to commercialization. Further, under this first-of-a-kind partnership, it is anticipated that a series of projects will be implemented to address these gaps with immediate benefit to the partners and public health. The Memorandum of Understanding (MOU) and recent press release for this Initiative are attached here for your convenient review.

In 2009, FDA and ANH jointly sponsored a second scientific workshop (May 6, 2009: Houston, Texas) as a follow-up to build on the accomplishments of the 2008 workshop. Again the meeting participants ranked this workshop extremely productive and successful.

2009 files


One of the first activities under FANTI, was a two and a half (2.5) day scientific workshop that was held on March 10-12th, 2008 in Houston, Texas. This Workshop was jointly sponsored by FDA and ANH. The first two (2) days of the Workshop was devoted to the identification of translational gaps and challenges in nanoengineered medical product development, along with an accompanying set of projects aimed at bridging such gaps. As FDA jointly sponsored this Workshop, these discussions were informed by regulatory input from senior FDA staff—all with the ultimate goal of stimulating innovation in nanotechnology and informing medical product development. The final half day was reserved for the presentations of the project concepts, and other findings as appropriate, to key stakeholders (i.e. finance, industry leaders, patient advocate foundations, etc.) to seek input on a final list of project recommendations. A summary of this workshop was captured in the attached publication: “Seven Challenges for Nanomedicine” in the Journal of Nature Nanotechnology (May 2008).     

2008 files



     
 
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