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Home > Nanotechnology Columns > Bergeson & Campbell, P.C. > FDA Finds Current Regulatory Review Processes Protect Public from Risks of Nanomaterials

Lynn L. Bergeson
Managing Director
Bergeson & Campbell, P.C.

Abstract:
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) posted a blog item on October 24, 2013, concerning the use of nanotechnology to develop new drugs.

October 29th, 2013

FDA Finds Current Regulatory Review Processes Protect Public from Risks of Nanomaterials

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) posted a blog item on October 24, 2013, concerning the use of nanotechnology to develop new drugs. See http://blogs.fda.gov/fdavoice/index.php/2013/10/as-nanotechnology-is-being-used-to-develop-new-drugs-fda-is-working-to-ensure-quality-safety-and-effectiveness/ According to the item, "[t]here are already many products made using materials at the nanoscale, including new kinds of clothing, packaging materials, and light-weight, but strong, building materials." CDER conducted a series of risk assessment and risk management exercises concerning drugs that contain nanomaterials to determine if its current regulatory processes are adequate to identify any potential risks and reduce those risks. CDER states that these exercises "determined that our current regulatory review processes indeed can adequately protect the public from potential risks associated with the use of nanomaterials in drug products." CDER also identified areas that could benefit from improvement, including "increased nanotechnology regulatory science research and up-to-date training of the review staff who evaluate marketing applications for drug products developed using nanomaterials." FDA will present the findings of these exercises at the January 14-15, 2014, workshop on "Nanomaterial Drug Products: Current Experience and Management of Potential Risks." See http://pqri.org/pdfs/Nano_Preliminary%20Program%20Brochure.pdf

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