By Mary Mosquera
The Food and Drug Administration is trying to increase the number and quality of electronic submission for drug applications. That is one of the foals of a five-year information technology plan to develop a more integrated, standards-based and automated regulatory e-submission and review environment.
Fda will have a draft by Dec, 31 and a final document by May 30, 2008.
The agency recieves more than 100,00 submission a year, 15 percent of which are submitted electronically, said Tim Stitely, FDA’s chief information officer.
“We’re seeing an uptake to about 40 percent for larger application being submitted electronically,” he said at a public meeting Oct. 19 on hoe IT can support the process to review drug applications.
FDA needs a modernized IT infrastructure to better support.