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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