FDA seeks more information on nanoparticles

August 22, 2012

The Food and Drug Administratio’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee has requested that the agency be more specific on what nanotechnology products it is regulating and how it is doing so.

Washington - The Food and Drug Administration’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee has requested that the agency be more specific on what nanotechnology products it is regulating and how it is doing so.

Pharmaceutical manufacturers are using nanotechnology in an increasing number of products. In a recent advisory committee meeting, it was noted the FDA has had difficulty deciding what nanotechnology information to require from the industries it regulates, MedPage Today reports. The agency is also unclear about which topics it should be further researching.

The FDA launched a nanotechnology task force in 2006. According to draft guidance issued by the FDA in 2011, nanotechnology is defined as engineered products with at least one dimension in the nanoscale range (1 nm to 100 nm) or products up to 1 micrometer, but which hold properties similar to nanomaterials.

Sunscreens were a particular area of concern during the meeting, as many contain nanoparticles to block UV rays. Recent research has raised concerns about potential complications arising from these particles, MedPage Today reports.

“It seems as if we have more questions than answers yet we continue to see a proliferation of this,” MedPage Today quotes Rodney Mullins, national director of Public Health Consultants and Advocates and an advisory committee panelist, as saying during the meeting.

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