FDA Approves Service Provider's Electronic Safety Reports

Sentrx has completed an FDA electronic submissions pilot and has begun sending individual case safety reports from a leading pharmaceutical company to the agency through the Electronic Standards for the Transmission of Regulatory Information (ESTRI) Gateway, the technology company said.

The FDA approved Sentrx for the pilot after the company sent test files to the agency with Relsys International's Electronic Submissions Manager, a module within the Relsys Argus Safety system, and Cyclone Commerce's Electronic Data Interchange, Sentrx said. The agency approved the pilot, in which Sentrx submitted both paper and electronic reports at once, and then permitted full-scale production after several successful transactions, said Sentrx, which is based in Little Falls, N.J.

Sentrx is working on a similar project with the European Medicines Agency, said Sentrx CEO Joseph Albano in a statement.

For more information about the ESTRI Gateway, go to http://www.fda.gov/oc/electronicsubmissions/interfaq.htm (http://www.fda.gov/oc/electronicsubmissions/interfaq.htm).