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OGD/OND system will help share reviews

Executive Summary

The Office of Generic Drugs is adopting a new information technology system that will enable it to share reviews with the Office of New Drugs, allowing both offices "full access to all available information of approved drug products," FDA announces Oct. 6. The new electronic Division File System provides OGD "document management, tracking, archiving, and electronic signature capabilities for internally generated review documents and search and retrieval capabilities for final versions of internally generated documents." FDA hopes the improved electronic repository for ANDA review and regulatory documents will improve the efficiency of the generic review process; OGD's mounting application backlog has come under fire over the last year (1"The Pink Sheet" Feb. 13, 2006, p. 7)...

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