I hope the GIVE Initiative really has made a difference at the FDA. I can't find any info showing how things have improved.
According to the Office of the Inspector General in their review of the ANDA process in 2006....
"According to CDER, 535 ANDAs (and corresponding amendments) were approved in 2006. CDER indicates that median approval time for these ANDAs and amendments was nearly 17 months."
65 cents boooom, page-4
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