According to InformationWeek, the FDA bureaucracy wants to change the document submission process by going totally electronic:
The Food and Drug Administration has tapped GlobalNet Services Inc., a systems integrator, and Cyclone Commerce Inc., a supplier of collaborative-business software, to develop an electronic-submissions gateway, a system to centralize document submissions to the FDA from pharmaceutical manufacturers and other federal agencies.
The gateway could be a pivotal development, as the health-care and pharmaceutical industries implement electronic-document systems and abandon inefficient paper-based processes.
The centralized system, a $2 million project to be unveiled this week, will replace several disparate electronic document submission systems operated by individual FDA organizations that regulate pharmaceuticals, medical devices, biologic products such as vaccines, and food products.
The first phase of the project, due in June, will allow pharmaceutical makers to submit documents seeking approval for new drugs. The FDA is pushing drug companies to use electronic documents to streamline the approval process and speed up after-market reports about drugs’ adverse effects.
Once the gateway is complete, in mid-2006, it will be the single point for electronic submissions from drug and medical-device companies, drug distributors, food makers, health-care organizations, and government agencies. The FDA exchanges volumes of documents with the National Institutes of Health, for example, and with the Drug Enforcement Administration, under the DEA’s program for tracking controlled drugs such as OxyContin.
The new system will provide a single standard for submitting documents to any organization within the FDA, says Michael Fauntleroy, director of the electronics submissions program at the FDA’s Center for Biologics Evaluation and Research, and project manager for the gateway project.