Report: FDA to speed up generic drug approval process
NAPLES, Fla. The Food and Drug Administration hopes to accelerate the review process for generic drugs, according to published reports.
In the face of a growing backlog of generic drug applications –– a number that increased from 515 in 2003 to 1,500 in 2008 –– FDA commissioner Margaret Hamburg said at the Generic Pharmaceutical Association’s annual meeting in Naples, Fla., that she would seek to implement a system of application fees to address funding shortages, the New York Times reported.
The FDA submitted its budget request to the Obama administration at the beginning of the month, requesting $51.5 million for the Office of Generic Drugs, $10 million more than it got last year.