Nanotech Regulatory Path UnclearNanotech Regulatory Path Unclear
Medical Device & Diagnostic Industry MagazineMDDI Article IndexOriginally Published MDDI August 2005NEWSTRENDS
August 1, 2005
Originally Published MDDI August 2005
CDER's Nakissa Sadrieh is encouraged by the rigorous guidelines
Is FDA sufficiently ready to regulate nanotechnology-based medical products? At a conference in May, the agency assured attendees that it is getting to that point, while industry experts were skeptical.
Nakissa Sadrieh, associate director for research policy and implemen-tation at the agency's Center for Drug Evaluation and Research, said that while a lot of evaluation remains to be done, FDA has been conducting a number of research proj-ects and participating in task forces on nanotechnology. She spoke at the NanoBusiness 2005 conference in New York City.
Encouraging, she said, is that “no safety concerns have ever been reported because of particle size.” That could mean regulation of nanoparticles may not differ much from regulation of molecular-sized particles, which CDER and, to a lesser extent, CDRH are accustomed to regulating.
Kereos CEO Robert Beardsley says that waiting for even higher standards may waste research time.
“We don't see the need for any specific testing requirements right now,” she said. “Our current requirements are rigorous.”
But much research must be completed before FDA comes to that conclusion. Among FDA's efforts is a CDRH/CDER study looking into developing IV assays to assess the technology of standard nano-particles. Many other studies are looking at toxicity issues.
“If our research identifies risks unique to nanomaterials, additional testing may become necessary,” explained Sadrieh. “New technology means unknown risks and limited scientific data. It's important for people to characterize what they are working with.”
Robert Beardsley, CEO of Kereos Inc. (St. Louis), a firm developing targeted therapeutics and molecular imaging agents, wasn't quite so optimistic that FDA wouldn't be an impediment to advances in nanotechnology.
“We are wasting a lot of time waiting for FDA to create a simple nano-tech regulatory environment,” said Beardsley, who spoke as part of a panel on the future of nanotechnology in healthcare.
“Consider what it went through with combination products, and how difficult that was to get straightened out. Now with nanotech, you will have products that will combine therapeutics and diagnostics. These are not things FDA has any capacity to deal with.”
Copyright ©2005 Medical Device & Diagnostic Industry
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