Infused with public and private investments, nanotechnology-based research and development is now burgeoning. The cumulative federal investment in nanoscale science and engineering research and development through the National Nanotechnology Initiative (NNI) over the last decade has reached nearly $14 billion ;  the 2011 NNI budget provides $1.76 billion spread across 15 federal agencies .  The unique and far-ranging properties of nanostructures and nanotechnology have particularly facilitated breakthroughs in the pharmaceutical and medical device realms. The interface of nanotechnology and biotechnology have increased bioavailability, introduced more targeted drug delivery and release, decreased adverse side effects, and enabled cutting-edge cancer treatments. Current projections place the “nanomedicine” market at $53 billion in 2011. 
Following its 2007 report, the FDA has taken a number of internal steps aimed at nanotechnology in addition to the recent guidance. FDA’s CDER and the Research Office of Pharmaceutical Science issued an internal Manual of Policies and Procedures (MaPP) in May 2010 that instructs drug reviewers to capture “relevant information about nanomaterial-containing drugs” that will be entered into a nanotechnology database.  The MaPP states that “in order to develop guidance for industry, CDER needs to organize all the data submitted in support of nanotechnology-based drug applications,”  gather all “relevant information about nanomaterial-containing drugs” and enter them into a nanotechnology database maintained by the agency.  While imposing no additional requirements on drug applicants, it signals recognition from the FDA of the nascent state of understanding of the complex scientific implications in human drugs.
nanostructured zein forming sub-micron size tubes, http://www.nano.gov/sites/default/files/zeinnanofabricatedbiomaterials_usda.pdf
FDA has also held several public meetings to gather nano-specific information: in October 2006 to aid the Task Force Report;  in September 2008 to assist the agency in implementing recommendations laid out in the Task Force Report;  and in September 2010 to solicit data and information on biocompatibility assessment of diagnostics and devices that include nanomaterials.  The FDA also maintains materials for the public on its webpage regarding nanotechnology. 
FDA is also partnering with the National Cancer Institute’s Nanotechnology Characterization Laboratory and the National Institute of Standards and Technology to conduct “preclinical efficacy and toxicity testing of nanoparticles” in an effort to identify appropriate standards for molecular-sized cancer drugs.  The FDA has identified risk characterization based on physical and chemical properties, in vitro and in vivo models to assist in predictions of human response to exposure, quantification methods, measures of adsorption and transport, and relationships between nanomaterial properties and the human body in terms of uptake via the skin, lungs, and gastrointestinal tract as specific areas of interest. 
Although moving slowly, the FDA is moving forward on issues of nanotechnology. Stay tuned… Prof. Paradise has an article forthcoming in Volume 56 of St. Louis University Law Journal on the topic of FDA regulation of nanotechnology entitled Reassessing ‘Safety’ for Nanotechnology Combination Products: What Do ‘Biosimilars’ Add to Regulatory Challenges for the FDA? Her research and publications, including her forthcoming article, can be found at SSRN http://ssrn.com/author=512260
 FDA Draft Guidance for Industry, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, June 9, 2011, available at http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm For more information, see also FDA Draft Guidance Questions and Answers, June 9, 2011, available at http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm258391.htm ; Jeffrey Ventura, FDA Press Release, FDA takes ‘first step’ toward greater regulatory certainty around nanotechnology, June 9, 2011, available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm258377.htm
 Office of Science and Technology Policy, Office of Management and Budget, and the United States Trade Representative, Policy Principles for the U.S. Decision-making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials, June 9, 2011, available at http://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/nanotechnology-regulation-and-oversight-principles.pdf
 Press Release, Food and Drug Administration, FDA Forms Internal Nanotechnology Task Force (Aug. 9, 2006), available at http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4241B1-02-33-FDA-Nano%20FDA%20News%20release.pdf .
 Food and Drug Administration Nanotechnology Task Force, Nanotechnology: A Report of the U.S. Food and Drug Administration Nanotechnology Task Force (2007), p. 20-21, available at http://www.fda.gov/nanotechnology/taskforce/report2007.pdf .
 The nanoscale is traditionally measured as under 100nm (or 10-9m, or one billionth of a meter). The National Nanotechnology Initiative (NNI) defines “nanotechnology” as involving three inter-related (and inseparable) aspects: “1) [r]esearch and technology development at the atomic, molecular or macromolecular levels, in the length scale of approximately 1-100 nanometer range; 2) creating and using structures, devices and systems that have novel properties and functions because of their small and/ or intermediate size; and 3) ability to control or manipulate at the atomic scale.” Environmental Protection Agency, Nanotechnology: An EPA Research Perspective (June 2007), http://nepis.epa.gov/Adobe/PDF/P1003H7X.PDF
 Office of Science and Technology Policy, NNI Strategic Plan 2010; Request for Information, 75 Fed. Reg. 38,850-53, 38,850 (2010).
 Raj Bawa & Summer Johnson, The Ethical Dimensions of Nanomedicine, 91 Med. Clinics N. Am. 881-87, 882 (2007), citing Nanotechnology in Healthcare (Cleveland: Freedonia Group 2007).
 Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, MaPP 5015.9 Reporting Format for Nanotechnology-Related Information in CMC Review (effective date June 3, 2010), available at http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/UCM214304.pdf.
 Id. at 2.
 Planning of Public Meeting, Regulated Products Containing Nanotechnology Materials, 71 Fed. Reg. 155, 46,232-33 (Aug. 11, 2006).
 Public Meeting, Consideration of FDA-Regulated Products That May Contain Nanoscale Materials, 73 Fed. Reg. 153, 46,022-24 (Aug. 7, 2008).
 Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations, 75 Fed. Reg. 162 (Aug. 23, 2010).
 Food and Drug Administration, Nanotechnology, http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/default.htm
 Food and Drug Administration, 2010 FDA Research Project Categories, http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm196697.htm