THE ROUNDUP

FDA Seeks 'Little' Information

Jun 1, 2006
Clare Kittredge

The US Food and Drug Administration plans to hold a public meeting this fall to hear from nanotechnology researchers about new developments and challenges involving the use of nanotech materials in FDA-regulated products. "The FDA needs to take a position to help guide product development that's on the cusp of happening," says Michael Arbige, senior vice president of technology for Genencor, a Palo Alto, Calif.-based biotech company that uses nanotech to develop products for the healthcare and biotech industries. "We're very anxious to hear the feedback."

Ted Sullivan, an analyst for New York City-based Lux Research, estimates the market for the use of nanotechnology in drug delivery systems at $1.3 billion for 2005, with a 35% annual growth rate projected for the next five years. "Nanotechnology is also being used in therapeutics," says Sullivan. He points to examples including Berlin-based MagForce Nanotechnologies, which is testing magnetic nanoparticles to burn away tumors; and Nanospectra Biosciences of Houston, whose president, Donald Payne, says the company expects to seek FDA approval to start a human trial of cancer therapy involving nanoparticles before the end of 2006.

In order to prepare for and guide the meeting, the agency is seeking feedback from researchers interested in attending the workshop, which it plans to hold in mid-October in the Washington, DC, area, according to the FDA. For more information, E-mail poppy.kendall@fda.hhs.gov.