FDA Urged to Develop Guidance on Nanotech-Based Drugs, Devices

July 27, 2007
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration’s Nanotechnology Task Force is urging the agency to develop a guidance and take steps toward addressing nanotechnology-based drugs and medical devices.

Rockville, MD (July 25)-The US Food and Drug Administration’s Nanotechnology Task Force is urging the agency to develop a guidance and take steps toward addressing nanotechnology-based drugs and medical devices. Commissioned by Andrew von Eschenback, MD, 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.”

Making these challenges more complex are the properties of nanometer-sized materials, particularly those affecting product safety and effectiveness. The report calls for “the need for ensuring transparent, consistent, and predictable regulatory pathways,” for FDA-regulated products stemming from nanotechnology, particularly as the knowledge base for its applications continues to grow and the “emerging and uncertain nature of nanotechnology” is explored.

The task force recommends that a draft guidance clarify the type of information sought by FDA about nano-based products and when the use of nanoscale materials may change the regulatory status of particular products. The report also suggests that FDA work to “assess data needs to better regulate nanotechnology products, including biological effects and interactions of nanoscale materials.” Moreover, the task force recommends that the agency develop in-house expertise to take into account future knowledge of nanotechnology and its applications, including adequate testing approaches for safety, effectiveness, and quality.