®: CRE Regulatory Action of the Week
Nanotechnology and the Data Quality Act
The FDA has convened an internal task force to "identify and recommend ways to address any knowledge or policy gaps that exist so as to better enable the agency to evaluate possible adverse health effects from FDA-regulated products that use nanotechnology materials."
As part of its work, the task force will hold "a public meeting to help FDA further its understanding of developments in nanotechnology materials that pertain to FDA-regulated products...."
The FDA's formation of the task force follows a Citizen Petition from the International Center for Technology Assessment (ICTA) requesting that the FDA take a series of measures with respect to products containing nanoparticles and a subsequent letter to the FDA from CRE requesting that the agency hold a public meeting on the petition.
The actions that ICTA requests that the Agency take include issuing "a formal advisory opinion explaining FDA's position regarding engineered nanoparticles in products regulated by FDA" and declaring that "all currently available sunscreen drug products containing engineered nanoparticles...as an imminent hazard to public health...."
CRE's letter to the FDA explained that "the Agency's regulation of all nanoengineered products, must comply with the Information Quality Act..." and that "the FDA's IQA Guidelines specifically apply to FDA's response to the Petition."
Click to read CRE Letter to FDA
Click to read FDA Press Release
Click to read FDA Week news story