Office of Generic Drugs Moves to the Division File System

Published: Fri Oct 06 00:00:00 -0400 2006

The Office of Generic Drugs (OGD) in the Food and Drug Administration (FDA) has adopted a new information technology system for reviewing and archiving Abbreviated New Drug Applications (generic drug applications or ANDAs) electronically.

OGD recently began using the Division File System (DFS) as a repository for Abbreviated New Drug Application (ANDA) review and regulatory documents in order to improve the efficiency of the generic review process. This version of DFS, which has been used by the Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER) since October of 2000, provides document management, tracking, archiving, and electronic signature capabilities for internally generated review documents and search and retrieval capabilities for final versions of internally generated review documents.

This system will now allow electronic archiving of ANDA documents for better tracking and search capabilities. It will also enable reviews to become part of the official electronic record for a specific generic drug application. DFS is also a mechanism for OGD and OND to have access to reviews completed in either Office, thus allowing full access to all available information on approved drug products.

"FDA has seen a significant growth in the number of generic applications received and we expect even more growth in the future," said Dr. Steven Galson, Director, Center for Drug Evaluation and Research, FDA. "Modernizing the tools we use internally to review these applications will help ensure a more efficient review and approval process."

"To tackle this increasing workload, and to enable improvements in the time it takes generic medicines to reach the market, FDA has introduced a number of process changes and other quality systems approaches to our work," said Gary Buehler, Director, Office of Generic Drugs. "Being able to electronically share documents with our new drug office counterparts provides a simple, yet significant, advancement to how we do our daily job."

In addition to today's announcement OGD has recently made a series of process improvements to the review of ANDAs which directly affects FDA review time and ultimately the availability of generic drug products. FDA has also posted on the Internet a database with dissolution information. This is very important information for sponsors of applications and decreases the requests to the agency, in turn freeing reviewer time. OGD is also working to encourage more widespread use of technology for the submission of applications.