/publications/issue/2006/2006-11/2006-11-6010

NEW FDA SYSTEM MAY SPEED GENERIC APPROVALS

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The FDA took a key step toward reducing the backlog of abbreviated new drug applications (ANDAs) with the creation of a new electronic filing system designed to speed up review times for generic drugs. Under the new system, the FDA's Office of Generic Drugs (OGD) will be able to search and archive generic drug applications on computers, rather than plow through hundreds of pages of printed text to process each ANDA.

"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," said Gary Buehler, director of the OGD. The FDA switched to the new electronic system to deal with what agency officials described as a "significant growth in the number of generic applications received" from manufacturers.

Between 2001 and 2005, the number of ANDAs received by the FDA more than doubled from 307 to 766, and "we expect even more growth in the future," said Steven Galson, MD, director of the FDA's Center for Drug Evaluation and Research. "Modernizing the tools we use internally to review these applications will help ensure a more efficient review and approval process."

The new electronic filing system is one of several recent process improvements adopted by the FDA to accelerate the review of ANDAs for new generic drugs. A new database posted by the FDA on the Internet saves time for generic drug sponsors by offering them on-line access to drug review information. Agency officials said they are also working to encourage more widespread use of technology for the submission of generic drug applications.