FDA: pre-IND meeting cuts development time

For all new drugs approved during 2010-12, the average clinical development time was more than three years faster when a pre-IND meeting was held with FDA than for approved drugs that did not have a pre-IND meeting, according to Anne Pariser, associate director for rare diseases at FDA's Center for Drug Evaluation and Research. The difference was even more stark for Orphan drugs, with an average development time that was six years shorter for Orphan drugs with a pre-IND meeting than for Orphan drugs developed without a meeting. ...