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October 2006 »

FDA Upgrades Generic Drug Review System

6 October, 2006

The Food and Drug Administration took one more step toward joining the information age Friday with the announcement of a new electronic filing system that could potentially speed up review times for generic drugs.

The new system will allow FDA scientists to search and archive generic drug applications on their computers, instead of sorting through hundreds of pages of hard copy.Agency officials said the upgrade will make product reviews more efficient, but industry representatives said changes beyond new technology are needed.

"This new electronic system must be backed up by increased congressional funding for the Office of Generic Drugs to hire needed staff and improve its overall administrative efficiency," said Kathleen Jaeger, president of the Generic Pharmaceutical Association.

The division of FDA that reviews first-of-a-kind drugs installed comparable technology six years ago.

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