October 24, 2006
FDA will offer speedy generic drug review times
Generic drugs considered important to the public health will now get quicker review times, FDA officials said.
Some generic drugs will now be prioritized to receive six-month reviews, rather than the median time of 16 months, CDER director Steven Galson said last Wednesday during a conference sponsored by the Generic Pharmaceutical Association.
As part of the plan, generic drug applications are eligible to undergo expedited review if they are to be used in public health emergencies, are in short supply, or if they do not already have a generic equivalent on the market and have no blocking patents.
Currently the FDA has a backlog of over 800 generic drugs awaiting approval under a process that evaluates applications in the order that it receives them. FDA deputy commissioner Scott Gottlieb told the Associated Press, “Given the important role generic drugs play in public health, we need to make sure the process is as efficient as possible.”