IT

US FDA issues IT improvement plan

The US Food and Drug Administration has published the information technology plan it will implement to achieve the performance goals agreed by the agency under the reauthorised Prescription Drug User Fee Act, PDUFA IV¹.

The PDUFA IV Information Technology Plan explains how the FDA intends to improve the automation of its business processes and maintain information systems that support its review of new drug applications². The agency envisages a fully electronic submission and review environment for all regulatory documents and data, and the elimination of paper-based submissions in the future. The plan, which can be accessed online at www.regulations.gov, will be updated periodically over the course of the PDUFA IV timeframe (fiscal years 2008-2012).

In November 2007, a report by the FDA's Science Board said that the agency's IT infrastructure lacked sufficient controls to ensure continuity of operations or to provide effective disaster recovery services³. The new IT plan is expected to address these shortcomings.

References

1. Federal Register, 30 June 2008, 73(126), 36880-36881, www.fda.gov/OHRMS/DOCKETS/98fr/E8-14744.htm

2. The Regulatory Affairs Journal - Pharma, 2008, 19(2), 139-140

3. FDA Science Board, FDA science and mission at risk, November 2007, www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf