1. 8. Does the product act like a device (providing, for example, structural support or mechanical action), or a drug (acting as a chemical agent, with targeted effects specific to a molecule), or a biologic (a serum, vaccine, or blood component)?.
2. 4. In contrast to existing drugs that target the influenza virus after it has already replicated inside human cells, nanoviricides target viruses in the bloodstream, before they infect cells. Hence, there is no need for the production of antibodies that vaccines would provide, and viral mutations are no longer significant. See Porter, N. and Hogle, L. F. , “Nanotechnology and Public Health: Redefining Risk and Containment,” manuscript in preparation.
3. 31. Currently, viral vectors are used to ferry genes to a location for gene therapy and to create induced pluripotent stem cells, potentially inducing cancers. As much as 50% of time in surgery is spent controlling bleeding. Self-assembly gels can seal the wound and quickly stop bleeding (see Jain, , supra note 6, at 191). Nanoneedles can be used in combination with atomic force microscopy to do “surgery” on living cells, entering the membrane while causing minimal damage (id., at 60).
4. 9. Many such hybrids had ambiguous modes of action. In these cases, sponsors were allowed to designate which Center would review their product. Not surprisingly, they chose the Center that would provide the easiest regulatory pathway. For an illustration with tissue engineered products, see Hogle, L. , “Pragmatic Objectivity and the Standardization of Human Tissues,” Social Studies of Science, forthcoming.