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“Onslaught of Nanotech Drugs Coming Down the Pike” (For FDA Review)

Posted by J. Steven Rutt on Posted in Nano Biotechnology; Nanotech Regulation; Patent

The September 3, 2012 issue of C&EN discusses what it calls an “onslaught of nanotech drugs coming down the pike” for FDA review.  See article entitled “Mapping Nanotech Drugs’ Landscape,” pp. 46, 48.

The FDA is generating a database for nanotech drugs and currently has 158 entries according to the article.  The leading application area is cancer treatment (38%).  Most are developed to be administered intravenously (56%).  The leading types of formulation are liposomes (39%) and nanoparticles (27%). 

The FDA will hold a public workshop in the coming months to get input from stakeholders for how to improve the review process.

The US patent literature confirms the role of nanotechnology innovation in cancer treatment.  Of the currently published nanotechnology class 977 patent filings (there are 13,814 of them), 1.9% of them refer to cancer in the title or abstract.  Considering the breadth of nanotechnology and bio nanotechnology, this is a significant fraction.  Also, 4.3% of them refer to cancer in the title, abstract, or claim.  Finally, 14.3% of them mention cancer in the patent somewhere.

 

 

Nanotech Regulatory Update: Will 2012 be the Year of Nano Regulations?

Posted by Sarah A. Slack on Posted in Nanotech Regulation

EPA and FDA both started 2012 by receiving criticism for their lack of management of nanomaterials in products the agencies regulate. EPA’s inspector general published a report released on December 29, 2011, entitled EPA Needs to Manage Nanomaterial Risks More Effectively in which the inspector general strongly criticizes the effectiveness of EPA’s management of nanomaterials. The report notes EPA’s failure to have in place a formal process to coordinate the distribution and use of information that companies are required to submit under existing regulations. One of the report conclusions is a recommendation that EPA should develop a way to gather and share nanomaterial information throughout the agency and with the public. A possible mechanism to achieve this would be to create a nanomaterials specific website. Although EPA’s response to the report lauded the “significant steps” the agency has taken to provide information regarding nanomaterials to the public, EPA has reportedly agreed to take additional steps to expand its existing procedures for sharing nanomaterial information between its various offices. 

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Nanomaterials Update — Federal Agencies Issue New Policy Guidance Documents on the Regulation of Nanomaterials

Posted by J. Steven Rutt on Posted in EPA; Nanotech Regulation

By Sarah Slack, Michael Flanagan, and J. Steven Rutt

In June 2011, several federal agencies issued policy guidance documents regarding the regulation of nanomaterials. Although the guidance documents were issued by several different agencies, including the Office of Management and Budget, the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA), they all convey the need to strike a careful balance between protecting human health, welfare, and the environment while fostering regulatory certainty for businesses on the forefront of innovation of nanomaterials and nanotechnology. The guidance documents issued by FDA and EPA were published in draft form, and public comments must be submitted by August 15, 2011, and July 18, 2011, respectively.

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