NEW FDA SYSTEM MAY SPEED GENERIC APPROVALS

Pharmacy Times, Volume 0, 0

The FDA took a key step towardreducing the backlog of abbreviatednew drug applications (ANDAs) withthe creation of a new electronic filingsystem designed to speed up reviewtimes for generic drugs. Under the newsystem, the FDA's Office of GenericDrugs (OGD) will be able to search andarchive generic drug applications oncomputers, rather than plow throughhundreds of pages of printed text toprocess each ANDA.

"Being able to electronically sharedocuments with our new drug officecounterparts provides a simple, yet significant,advancement to how we doour daily job," said Gary Buehler, directorof the OGD. The FDA switched to thenew electronic system to deal withwhat agency officials described as a"significant growth in the number ofgeneric applications received" frommanufacturers.

Between 2001 and 2005, the number ofANDAs received by the FDA more thandoubled from 307 to 766, and "we expecteven more growth in the future," saidSteven Galson, MD, director of the FDA'sCenter for Drug Evaluation and Research."Modernizing the tools we use internallyto review these applications will helpensure a more efficient review andapproval process."

The new electronic filing system isone of several recent process improvementsadopted by the FDA to acceleratethe review of ANDAs for new genericdrugs. A new database posted by theFDA on the Internet saves time forgeneric drug sponsors by offering themon-line access to drug review information.Agency officials said they are alsoworking to encourage more widespreaduse of technology for the submissionof generic drug applications.