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A Nano-Challenge for FDA

Under the title Regulating Nanomedicine – Can FDA handle it?, a recent review article in WeSRCH (MedTech) online investigates the US Food and Drug Administration’s (FDA) ability to fulfil its duty in providing 'clarity and legal certainty to manufacturer, policymakers, healthcare providers and the public' on the topic of nanomedicine. The author claims that 'regulators struggle to accumulate data and formulate testing criteria to ensure development of safe and efficacious nanoproducts (products incorporating nanoscale technologies)'.

The article is based on a few assumptions of the FDA’s Nanotechnology Task Force (NTF); the author stated that '[…] according to the FDA if large particle versions of a product are considered to be safe, then it can be presumed that the nanoversions are safe as well'. The fact that FDAcreated the NTF and formed a policy on dealing with nanomaterials is a strong proof in contradiction to views expressed in the article, however. In 2007, NTF published a report after a consultation stating that '[t]he Task Force also assessed the agency's regulatory authorities to meet any unique challenges that may be presented by FDA-regulated products containing nanoscale materials'.

FDA’s position regarding the nanotechnology applications in medical products was challenged by the current article in the following areas:

  • Safety and risk assessment of nano-products
  • Safety Data accumulation and sharing
  • Standardisation
  • Monitoring and detection tools
  • Nano-product classification scheme

In reality the FDA does distinguish between nano and non-nano products and has an ongoing strategy directed by the NTF: "The Task Force continues to identify and recommend ways to address any knowledge or policy gaps that exist so as to better enable the agency to evaluate possible adverse health effects from FDA-regulated products that use nanotechnology materials".


Follow this link to find out more about the FDA's Nanotechnology Task Force (NTF), or to download the full MedTech article.

News item was produced by NIA in association with BREC Solutions.

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