FDA selects electronic submissions vendors

PDUFA information

Food and Drug Administration officials have chosen vendors to develop a system for accepting electronic document submissions. The Electronic Submissions Gateway project will centralize the submissions that FDA gets from the companies it regulates and from other government agencies.

GlobalNet Services Inc. (GNSI) and Cyclone Commerce will work as partners in developing the gateway, company officials said. GNSI employees will start with Cyclone's most powerful business-to-business e-commerce platform, Cyclone Interchange, as a foundation for the system. Cyclone will also contribute other products and domain expertise to the project, GNSI officials said.

The initial phase of the gateway will center on Prescription Drug User Fee Act submissions, which covers the application forms and fees that companies must submit to get the FDA to evaluate new prescription drugs for approval. Eventually, the gateway will provide a single point of entry for all document submissions the FDA takes.

GNSI is the prime contractor on the $2 million contract.