FDA issues industry guidance on use of nanotechnology

The U.S. Food and Drug Administration has released four documents seeking to clarify its stance on the use of nanotechnology in FDA-regulated products.

After taking public comment, the agency issued final guidance on nanotechnology in products it regulates overall and documents specific to food and cosmetics. Draft guidance was issued on use of nanotechnology in food for animals. The FDA will take public comment on that document through Sept. 10.

All four documents encourage manufacturers to consult with the agency early in their development process to consider potential implications for safety, effectiveness and public health.

"Our goal remains to ensure transparent and predictable regulatory pathways, grounded in the best available science, in support of the responsible development of nanotechnology products," FDA Commissioner Margaret Hamburg said in an announcement.

Researchers continue to find new uses for nanotechnology in medicine. The Massachusetts Institute of Technology has developed a "stealth" drug delivery system to attack a type of breast cancer that is highly resistant to current therapies.

Other research out of MIT has found that carbon nanotubes can act as sensors for up to a year when implanted under the skin or injected into the bloodstream for short-term monitoring.

In addition, Belgian researchers have developed a selective revolving door through a cell's lipid membrane that could be used in targeted drug delivery.

To learn more:
- read the announcement
- here's the final guidance on regulated products (.pdf)
- here's the final guidance specific to food
- here's the final guidance specific to cosmetics
- here's the draft guidance (.pdf)

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