Vendors for FDA's Electronic Submissions Gateway Selected

The FDA's Electronic Submissions Gateway has moved a step closer to reality as the agency selected the vendors that will build the system, a central collection portal for electronic submissions from FDA-regulated industries and other government agencies.

The new system, which can accept electronic submissions as large as 100 gigabytes, will replace the Electronic Regulatory Submissions and Review Gateway, which can only handle submissions of 150 kilobytes or less. Last year, the FDA said it had delayed the gateway implementation timeline because of contracting issues but expected to roll out the first phase of the project by mid-2005.

The upgraded system is expected to make the submission process much less arduous for drugmakers, which now have to submit multiple documents to the agency because the current system can't handle the large electronic files contained in standard drug applications.

The gateway will focus initially on Prescription Drug User Fee Act-related submissions, according to GlobalNet Services of Rockville, Md., and Cyclone Commerce of Scottsdale, Ariz., which are working in partnership to build the gateway.