FDA Adopts New IT System to Improve Drug Application Reviews

Faced with a huge backlog of generic drug applications, the FDA’s Office of Generic Drugs (OGD) announced it is now using an electronic filing system — in use by another division of the FDA since 2000 — that the OGD said will make it more efficient at reviewing applications.

The Division File System (DFS), currently being used by the Center for Drug Evaluation and Research’s (CDER) Office of New Drugs (OND), will give the OGD document management, tracking, archiving, electronic signature and search and retrieval capabilities for internally generated review documents, the agency said Oct. 6.

The DFS will also make application reviews part of the official electronic record for a specific generic drug application. Both the OGD and the OND will have access to reviews completed in either department, which will give them access to all available information on approved drug products.

OGD Director Gary Buehler and CDER Director Steven Galson said the system would help the OGD manage the increasing number of generic drug applications it receives.

The OGD said earlier this year that it expected to receive about 800 applications in fiscal 2006, up from 766 in fiscal 2005.

Kathleen Jaeger, president and CEO of the Generic Pharmaceutical Association, said the group welcomes “technological improvements and OGD’s efforts to bring greater efficiency to the generic drug approval process.”

But she added that the new system “must be backed up by increased congressional funding for OGD to hire needed staff and improve its overall administrative efficiency.”