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The Biomedical Engineering blog is the place for conversation and discussion about topics related to engineering principles of the medical field. Here, you'll find everything from discussions about emerging medical technologies to advances in medical research. The blog's owner, Chelsey H, is a graduate of Rensselaer Polytechnic Institute (RPI) with a degree in Biomedical Engineering.

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Is the FDA Ready for Nanotechnology?

Posted October 06, 2006 5:03 PM by Steve Melito
Pathfinder Tags: FDA nanotechnology

Michael Taylor is worried. Yesterday, the former deputy commissioner for policy at the U.S. Food and Drug Administration warned that "there are some gaps in FDA's legal authority" when it comes to nanotechnology. In a report commissioned by the Woodrow Wilson Center's Project on Emerging Nanotechnologies, Taylor blamed these legal loopholes for "FDA's inability to acquire information about nanotechnology products early enough in their development to prepare properly for their regulations." The problems don't stop there, however. According to Taylor, the FDA faces severe budgetary constraints and a lack of nano-expertise.

Dave Rejeski, director of the Project on Emerging Nanotechnologies, is also concerned. "There are enormous amounts of investment at stake", Rejeski told UPI. The U.S. government has invested $1.3 billion in nanotech research and the private sector has spent $1.7 billion. There are now over 300 nano-products on the market and 200 drugs and medical devices that use nanotechnology in the works. "The market size for drug delivery", says Rejiski, "is almost $1 billion and is expected to grow about 50 percent over the next 5 years".

It's been said that what you don't know can't hurt you - and that ignorance is bliss. Guess how many Americans don't even know what nanotechnology is . . .

Steve Melito - The Y Files

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Anonymous Poster
#1

Re: Is the FDA Ready for Nanotechnology?

10/08/2006 11:25 AM

After many years of fiascos with the FDA banning such harmless substances such as Clove Oil for tooth problems and confiscation of low cost drugs from Canada just to prop up the big drug companies, maybe we need to think about scrapping this bunch of corporate bozos. Maybe it is a good thing they know nothing of the Nano technology. Good things might actually have a chance of making it to market in the US. Roy

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Anonymous Poster
#2
In reply to #1

Re: Is the FDA Ready for Nanotechnology?

10/08/2006 10:02 PM

Roy,

Nanotechnology does have a potential for great things in the market. But it is far from a good thing for the FDA to know nothing about N.Tech. N.Tech can pose a huge threat to the environment and to the well being of those who ingest Nano particals.

Nanotechnology will lead to new materials never before imagined which will literally revolutionize the way we live and the things we build. Certain structures which were unimaginable before will be constructed using "super-materials" which will be the result of nanotechnology.

Imagine nano-robots which can be programmed to travel through your bloodstream to certain locations in your body to detect and treat medical problems. Non-invasive ways of treating all sorts of medical conditions will result from nanotechnology in the future.

NanoTech literally changes the chemical properties of materials which in turn will increase combustion efficiencies of fuels. But beware...this is also true for weapons.

The problem is, however, that there is not enough objective evidence about the impact these materials will have on the environment. We don't know if the use of nanotechnology in fuels will create nano-polution which our bodies will be able to handle.

If the FDA goes ahead and puts a ban on the technology, then a black market will emerge with nothing to watch over it and ensure that it is managed with care. On the other hand, if the FDA does not act at all, the consequences could also be disasterous. One thing that the article above does not mention is the amount of research being done around the world. We are not the only ones interested in nanotechnology and we are not the only ones capable of developing it. If we do nothing, we will be left behind.

Nanotech. has an impact on almost every industry imaginable, and there simply has not been enough research into the possible hazzards involved with it. I tell you now, whether we are ready for it or not, a nanotechnology revolution is coming and it will change our lives. The question is whether we are responsible enough to prevent it from destroying us.

I would like to hear from anyone well versed on the subject to put my comments in line. I do not believe that I am over-reacting though some of you might. Before you shrug off what I have said, please look into it and do some research because nanotech is not some isolated irrevelant technology. Being able to manipulate mechanical systems at a molecular level is something that will give us tremendous abilities but also poses a very grave danger.

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Join Date: Jun 2007
Location: Lexington, Kentucky, USA
Posts: 33
#3
In reply to #2

Re: Is the FDA Ready for Nanotechnology?

06/29/2007 7:07 AM

Nanotechnology poses some serious questions about health safety. Are nanoparticles capable of penetrating the cellular membrane? What happens if they do? Will it interfere with cellular metabolism? What about cellular reproduction? Do the have carcinogenic potential?

These are all questions that I am concerned about. There are some people that may think these are trivial questions but I would rather be safe than sorry.

Mike

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