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Passing the bug: FDA answers calls for industry guidance with requests for more industry information
During the 2nd Annual Conference on Nanotechnology Law, Regulation and Policy (organised by the US Food and Drug Law Institute, held in Washington DC on the 18th and 19th February 2009), a delegation from various centers and offices of the US Food and Drug Administration (FDA) commented on the question whether the FDA was planning to provide guidance to industry, as recommended in the FDA’s Nanotechnology Task Force report in July 2007.
As reported by Lynn Bergeson on Nanotechnology Law Blog, ‘Associate Center Director for Post-Market Operations at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), stated that FDA will not issue guidance until companies bring products to them so that FDA can learn more about the effects of nanotechnology. [...]'
Deputy Director Douglas Throckmorton, FDA Center for Drug Evaluation and Research (CDER), stated: “We are at work understanding what we have at hand, developing a full inventory of nanoscale products before we get into the guidance business. But I will say this, we know much less than we need to on the effect of nanoscale materials on manufacturing.”
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Registered NIA Members can now download the following exclusive documents (i.e. Meeting Presentations, Meeting Notes, etc.), recently uploaded onto the secure
‘Members only’-area of the NIA website.
18th – 19th February 2009
2nd Annual Conference on Nanotechnology Law, Regulation and Policy
(organiser: Food and Drug Law Institute (FDLI), Washington DC; held at L’Enfant Plaza Hotel, Washington DC) (1st March 2009)
Reporting from the 2nd Annual Conference on Nanotechnology Law, Regulation and Policy (organised by the US Food and Drug Law Institute, held in Washington DC on the 18th and 19th February 2009), a conference delegate, Rick Weiss, Senior Fellow at the Center for American Progress and Science Progress, sums up his impression of the debate with the words: ‘Whether it’s about suing or being sued, it seems that nanotechnology—and every other new technology with a still-uncertain benefit-to-risk ratio—is a 21st century Full Employment Act for attorneys.’ (23rd February 2009)