FDA ready to speed products
This article was originally published in Clinica
After last month's terrorist attack on the US, FDA device regulators scrutinised product applications on hand to see if whether any submissions should be accelerated. An early concern was whether there were any pending applications for burns products that were being held up because the agency had yet to inspect the manufacturing facility, David Feigal, director of the Center for Devices and Radiological Health told Clinica. It has also considered whether to help accelerate review of products that might be useful in diagnosing the presence of a bioterrorist agent.