In November 2016, the Chair of the Nanomedicines Alliance co-edited the AAPS Special Theme Issue Nanotechnology in Complex Drug Products: Learning from the Past, Preparing for the Future.
Nanomedicines: From Bench to Bedside and Beyond. The AAPS Journal, November 2016, Volume 18, Issue 6, Pages 1373–1378.
The nanomedicines alliance: an industry perspective on nanomedicines. Nanomedicine: Nanotechnology, Biology, and Medicine, November 2014, Volume 10, Issue 8, Pages 1819–1820.
Nanomedicine Drug Development: A Scientific Symposium Entitled Charting a Roadmap to Commercialization. This paper was based on the findings of the 2013 Nanomedicines Alliance Symposium and is available from the AAPS Journal.
Summary Report of PQRI Workshop on Nanomaterial in Drug Products: Current Experience and Management of Potential Risks. The Nanomedicines Alliance presented at this 2013 PQRI Workshop on Nanomaterials in Drug Products and contributed to the proceedings paper.
Comments on Guidances
Comments On NNI 2014 Strategic Plan
Comments On NIOSH Nanotechnology Research and Guidance Strategic Plan 2013‐2016
Comments On FDA Draft Guidance for Industry
Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology
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Presentations and Other Materials
In September 2016 Clarice Hutchens from the Nanomedicines Alliance presented at the Global Summit on Regulatory Science: Nanotechnology Standards and Applications.
The Nanomedicines Alliance has developed a list of nanomedicine drugs currently approved and on the market, as of July 2016.
In October 2015, the Dr. Marc Wolfgang from Nanomedicines Alliance presented on the particle size analysis project at the 2nd FDA/PQRI Conference on Product Quality. Another member, Dr. Donald Parsons, also presented on Industrial Perspective on Nanomedicine Characterization Strategies.
In January 2014, the Alliance presented on risk assessment and management at the PQRI workshop on nanomaterial drug products. The presentation from the workshop is available here.
In October 2013, the Nanomedicines Alliance met with the CDER Nanotechnology Risk Assessment Working Group to discuss potential collaboration opportunities.