FDA nanotechnology report outlines scientific and regulatory challenges
The US FDA's Nanotechnology Task Force has recommended in a new report that the agency consider developing guidance and taking other steps to address the benefits and risks of drugs and medical devices using nanotechnology.
The US FDA's Nanotechnology Task Force has recommended in a new report that the agency consider developing guidance and taking other steps to address the benefits and risks of drugs and medical devices using nanotechnology.
Initiated in 2006, the Task Force reports that nanoscale materials potentially could be used in most product types regulated by FDA and that those materials present challenges similar to those posed by products using other emerging technologies. The challenges, however, may be complicated by the fact that properties relevant to product safety and effectiveness may change as size varies within the nanoscale.
The report also says that the emerging and uncertain nature of nanotechnology and the potentially rapid development of applications for FDA-regulated products highlight the need for ensuring transparent, consistent, and predictable regulatory pathways.
Anticipating the potential for rapid development in the field, the report recommends consideration of agency guidance that would clarify, for example, what information to give FDA about products, and also when the use of nanoscale materials may change the regulatory status of particular products.
In addition, the report says the FDA should work to assess data needs to better regulate nanotechnology products, including biological effects and interactions of nanoscale materials. The agency also should develop in-house expertise and ensure consideration of relevant new information on nanotechnology as it becomes available, according to the report. FDA should evaluate the adequacy of current testing approaches to assess safety, effectiveness and quality of nanoscale materials.
"Nanotechnology holds enormous potential for use in a vast array of products," said Dr Commissioner of Food and Drugs Andrew von Eschenbach. "Recognising the emerging nature of this technology and its potential for rapid development, this report fosters the continued development of innovative, safe and effective FDA-regulated products that use nanotechnology materials."