Nanotechnology and Oncology Workshop Summary (2011) / Chapter Skim
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5 Standards and Regulation
5 Standards and Regulation
Pages 53-62
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From page 53... ...
, Dr. Kulinowski pointed out that there are numerous challenges involved in regulating nanotechnology because of a diversity of nanomaterials and their applications, a lack of characterization data, and a lack of standardization in nomenclature, metrics, and materials, and possibly inadequate statutory authority.
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From page 54... ...
The agency regulated nanomaterials as falling under the domain of the Toxic Substances Control Act, and engaged in a voluntary data gathering approach initially. But now the EPA is starting to define nanoscale materials as new uses of existing chemicals, she said, which allows the agency to impose some additional reporting requirements, toxicology testing, and specific mandates for worker protection, as well as mandatory data collection.
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From page 55... ...
Dr. McNeil noted that standards development is one of the goals of the Nanotechnology Characterization Laboratory and that it has collaborated with the ISO and the ASTM to finalize three formal voluntary consensus standards for biocompatibility testing of nanomaterials intended for medical applications.
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From page 56... ...
I certainly wish more of that were done for the so-called targeted molecular therapies, because for many of them, we don't even know that that they are actually hitting their target." Dr. Josephson noted that for nanomedicines that are injected, the regulatory framework is well established "because there's a long history that precedes the word nano.
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From page 57... ...
Gaspar applauded FDA's combination product regulation pathway, but in regards to diagnostics that can predict who will respond to specific therapeutics and should therefore undergo regulatory review simultaneously with the therapeutic, Dr. Gaspar added, "On both sides of the Atlantic we haven't found a common regulatory path that can look at this in an integrated form."
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From page 58... ...
"We don't have the possibility, based only on physical–chemical data, to translate equivalence between the innovative product and its generic version." Dr. Gaspar noted that the classical regulatory approach for a generic product formulated as an intravenous aqueous solution, such as iron oxide colloids for iron replacement therapy, does not require pharmacokinetic assessments, even if the formulation contains nanoparticles.
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From page 59... ...
Dr. Kulinowski noted recent attempts various states have made to close regulatory gaps they see in nanotechnology oversight.
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From page 60... ...
Dr. SacknerBernstein noted a recent fruitful collaboration between DARPA and the FDA in the development of blood farming using stem cells, which he said could serve as a model for collaboration between government agencies.
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From page 61... ...
A report from that workshop will identify issues and emerging science aspects, which may assist future developments in the field and be relevant to future regulatory considerations.
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