FDA Publishes Plan to Improve IT Infrastructure

Rockville, MD (Dec. 28)-The US Food and Drug Administration released a draft plan for modifying its information technology (IT) infrastructure. The plan follows the renewal of the Prescription Drug User Fee Act (PDUFA IV) in 2007. The agency will develop, implement, and maintain new information systems for human-drug review throughout the product life cycle.

According to the draft plan, FDA intends to improve its ability to communicate information internally and externally and effectively supply technology tools and services to the FDA user community. The agency’s long-term goal is to create an automated, fully electronic, standards-based, submission-and-review environment for human drugs.

Specific projects described in the plan include:

• Updating technical specifications and IT-related guidance documents to reflect consistent program-wide implementation of new systems supporting electronic information exchange between FDA and regulated parties

• Improving the secure, electronic, single point of entry to enable the two-way transmission of regulatory correspondence

• Establishing an automated, standards-based, regulatory submission and review environment for investigational new drugs, new drug applications, biologic license applications, and their supplements

• Establishing a standards-based system for the electronic exchange and management of human-drug labeling information

• Establishing standards-based IT systems to support the acquisition and analysis of postmarket drug-safety data.

In the draft, FDA said it must perform near-term planning and make strategic investment decisions during the first year of PDUFA IV. The agency is conducting studies to develop a strategy for modernizing its IT infrastructure and services. FDA also plans to centralize its IT decisionmaking and governance. In addition, the agency recognized the need to resolve technical and policy concerns before establishing standard methods for the secure exchange of information with industry.

FDA is soliciting public comments about the plan. Comments are due Feb. 22, 2008. The agency intends to review the comments, revise the plan, and publish the final version of the plan by May 30, 2008.